510(k) Report

510(k) · Cleared

Cleared

CBC-STK (TM) Hematology Control/Multiple

K934497510(k) TraditionalCleared Dec 6, 199383-day reviewClass II21 CFR 864.8625

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

R&D Systems, Inc. · JCN Control, Cell Counter, Normal And Abnormal

Cleared on Dec 6, 1993 after an 83-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.

Decided
Dec 6, 1993
Review
83 days
Class
Class II
Product code
JCN
Recalls
None
Predicates
0

4 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2007: 1 descendant cleared2006: 1 descendant cleared2013: 1 descendant cleared1990200020102020
  1. This deviceK934497 CBC-STK (TM) Hematology Control/MultipleR&D Systems, Inc. · 1993
  2. Descendant · cites it directly · 3 of its ownK983032 CBC-5D Hematology ControlR&D Systems, Inc. · 1999
  3. Descendant · 2 generations on · 1 of its ownK072096 CBC-5D Plus Retics Hematology Control, Models: 5DR03, 5DR04R&D Systems, Inc. · 2007
  4. Descendant · 3 generations on · 0 of its ownK130962 R&D 5D Retic Hematology ControlR&D Systems, Inc. · 2013
  5. Descendant · 2 generations on · 0 of its ownK061320 R&D LH-NRBC Hematology ControlR&D Systems, Inc. · 2006

Most influential descendants

Showing 4 of 4 · See all
  • K983032CBC-5D Hematology ControlR&D Systems, Inc. · 1999 · cites it directly3descendants
  • K072096CBC-5D Plus Retics Hematology Control, Models: 5DR03, 5DR04R&D Systems, Inc. · 2007 · 2 generations on1descendant
  • K130962R&D 5D Retic Hematology ControlR&D Systems, Inc. · 2013 · 3 generations on0descendants
  • K061320R&D LH-NRBC Hematology ControlR&D Systems, Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K934497CBC-STK (TM) Hematology Control/MultipleR&D Systems, Inc.1993—
+1K983032CBC-5D Hematology ControlR&D Systems, Inc.1999—
+2K072096CBC-5D Plus Retics Hematology Control, Models: 5DR03, 5DR04R&D Systems, Inc.2007—
+3K130962R&D 5D Retic Hematology ControlR&D Systems, Inc.2013—
+2K061320R&D LH-NRBC Hematology ControlR&D Systems, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200610
200710
201310
FIG. 1 — Lineage of K934497, 1993–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JCN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K983032CBC-5D Hematology ControlR&D Systems, Inc.19993

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K983032 (R&D Systems, Inc., 1999) has gone furthest, with 3 descendants of its own.

How does its category compare?

All JCN devices

JCN Control, Cell Counter, Normal And Abnormal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JCN

FDA has decided no JCN device since 2007.

Median 510(k) review, days · JCN

Too few JCN 510(k)s in any year since 2007 to give a median.

Recalls per year · JCN

No recall names JCN since 2007.

Adverse event reports per year · JCN

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code JCN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—02
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from R&D Systems, Inc.

79 FDA decisions under this applicant name. See the company

  • K160606BC-5D Hematology ControlR&D Systems, Inc. · 2016
  • K130962R&D 5D Retic Hematology ControlR&D Systems, Inc. · 2013
  • K101578R&D Systems Body Fluid-I Hematology ControlR&D Systems, Inc. · 2011
  • K100050R & D Systems Xeret Hematology ControlR&D Systems, Inc. · 2010
  • K091433R&D Systems Tetic-I Plus Hemotology ControlR&D Systems, Inc. · 2009

Recent decisions in JCN

The JCN category page

  • K993825Para Tech Plus ReticsStreck Laboratories, Inc. · 19993 recalls
  • K942209Liquichek Hematology-16 Control, Low, Normal and HighBio-Rad · 1994
  • K911582Stak-ChexStreck Laboratories, Inc. · 1991
  • K902391Cell-Dyn 3000 ControlUnipath, Ltd. · 1990
  • K902389Tri-Count 16Hematronix, Inc. · 1990

https://510kreport.com/device/K934497 · printed Nov 6, 2026

Cite this page

510(k) Report. “K934497: CBC-STK (TM) Hematology Control/Multiple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934497

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026