510(k) Report

510(k) · Cleared

Cleared

Pat Platelet Aggregation Test

K881829510(k) TraditionalCleared Jul 1, 198863-day reviewClass II21 CFR 864.6675

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

Streck Laboratories, Inc. · JBX Aggregrometer, Platelet

Cleared on Jul 1, 1988 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 1, 1988
Review
63 days
Class
Class II
Product code
JBX
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K881829Source: FDA 510(k) database · 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 JBX? 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All JBX devices

JBX Aggregrometer, Platelet: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JBX

FDA has decided no JBX device since 2007.

Median 510(k) review, days · JBX

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

Recalls per year · JBX

No recall names JBX since 2007.

Adverse event reports per year · JBX

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2025

MAUDE reports naming product code JBX, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Streck Laboratories, Inc.

70 FDA decisions under this applicant name. See the company

  • K042587Retic-Chex for Cell-DynStreck Laboratories, Inc. · 2004
  • K040107Cyto-Chex BCTStreck Laboratories, Inc. · 2004
  • K040025A1C-CellularStreck Laboratories, Inc. · 2004
  • K023656Sickle-Chex Solubility KitStreck Laboratories, Inc. · 2002
  • K021922Modification to Para 5XStreck Laboratories, Inc. · 2002

Recent decisions in JBX

The JBX category page

  • K932566Aggro/Link Control SoftwareChrono-Log Corp. · 1993
  • K912774Arachidonic AcidHelena Laboratories · 1991
  • K862775Asserachrom B-TG KitAmerican Bioproducts Co. · 1986
  • K851025Aggro/Link Computer InterfaceChrono-Log Corp. · 1985
  • K850592Platelet Aggregation ReagentChrono-Log Corp. · 1985

https://510kreport.com/device/K881829 · printed Nov 4, 2026

Cite this page

510(k) Report. “K881829: Pat Platelet Aggregation Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K881829

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