510(k) Report

510(k) · Cleared

Cleared

Immulon 1,2,3,and 4 Dividastrips TM

K894645510(k) TraditionalCleared Oct 17, 198985-day reviewClass I21 CFR 866.2500

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

Dynatech Laboratories, Inc. · JTC Device, Microtiter Diluting/Dispensing

Cleared on Oct 17, 1989 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 17, 1989
Review
85 days
Class
Class I
Product code
JTC
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K894645Source: 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 JTC? 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 JTC devices

JTC Device, Microtiter Diluting/Dispensing: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JTC

FDA has decided no JTC device since 2007.

Median 510(k) review, days · JTC

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

Recalls per year · JTC

1in 2009

2007: 12008: 12009: 1
2007high 1 (2007) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JTC

8in 2025

2007: 1,1182008: 9192009: 3882010: 1902011: 472012: 12013: 12014: 22015: 12019: 1022020: 22021: 82022: 262023: 152024: 102025: 8
2007high 1,118 (2007) · low 0 (2016)2025

MAUDE reports naming product code JTC, 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—11,118
20080—1919
20090—1388
20100—0190
20110—047
20120—01
20130—01
20140—02
20150—01
20160—00
20170—00
20180—00
20190—0102
20200—02
20210—08
20220—026
20230—015
20240—010
20250—08
20260—0—

More from Dynatech Laboratories, Inc.

44 FDA decisions under this applicant name. See the company

  • K962265MLX Microtiter Plate LuminometerDynatech Laboratories, Inc. · 1996
  • K934111MR7000 with Time Manager Software (TMS)Dynatech Laboratories, Inc. · 1994
  • K943701MRX Microplate ReaderDynatech Laboratories, Inc. · 1994
  • K923456Microlite Microtiter Plate Luminometer ML3000Dynatech Laboratories, Inc. · 1992
  • K915896Microlite Microtiter Plate Luminometer ML2250/ModiDynatech Laboratories, Inc. · 1992

Recent decisions in JTC

The JTC category page

  • K924907Filtermate Universal HarvesterPackard Instrument Co., Inc. · 1992
  • K901808Micromate 196 Model A961960Packard Instrument Co., Inc. · 1990
  • K892369Multi-Probe Head PlusHamilton Co. · 1989
  • K891765Genetic Systems Pipettor/DilutorGenetic Systems Corp. · 1989
  • K891768Genetic Systems Microplate WasherGenetic Systems Corp. · 1989

https://510kreport.com/device/K894645 · printed Nov 4, 2026

Cite this page

510(k) Report. “K894645: Immulon 1,2,3,and 4 Dividastrips TM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K894645

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