510(k) Report

510(k) · Cleared

Cleared

Uritec Test Strip & Human Urine + & - Test Control

K912888510(k) TraditionalCleared Feb 24, 1992238-day reviewClass U

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

Dynagen, Inc. · MIG Strip, Test Isoniazid

Cleared on Feb 24, 1992 after a 238-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Feb 24, 1992
Review
238 days
Class
Class U
Product code
MIG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K912888Source: 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 MIG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • 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?

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 MIG devices

MIG Strip, Test Isoniazid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MIG

FDA has decided no MIG device since 2007.

Median 510(k) review, days · MIG

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

Recalls per year · MIG

No recall names MIG since 2007.

Adverse event reports per year · MIG

2in 2017

2017: 2
2007high 2 (2017) · low 0 (2007)2025

MAUDE reports naming product code MIG, 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—00
20170—02
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Dynagen, Inc.

6 FDA decisions under this applicant name. See the company

  • K963733Niccheck IDynagen, Inc. · 1996
  • K943051Mycoakt M. Tuberculosis Cuulture ID KitDynagen, Inc. · 1995
  • K943049Mycoakt M. Avium Culture ID KitDynagen, Inc. · 1995
  • K943050Mycoakt M Kansasii Culture ID KitDynagen, Inc. · 1995
  • K931105Procheck (TM) Blind Performance SpecimensDynagen, Inc. · 1993

Recent decisions in MIG

The MIG category page

  • K962615Tumorlocalizer MriFerguson Medical · 1998

https://510kreport.com/device/K912888 · printed Nov 4, 2026

Cite this page

510(k) Report. “K912888: Uritec Test Strip & Human Urine + & - Test Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K912888

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