510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912888Substantially Equivalent

Uritec Test Strip & Human Urine + & - Test Control

Dynagen, Inc., Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912888 is the FDA 510(k) clearance record for URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL, cleared for Dynagen, Inc. on under FDA product code MIG (Strip, Test Isoniazid). FDA records list 6 510(k) clearances for Dynagen, Inc., from to . As of , FDA records show no recalls naming K912888.

Clearance record

Decision date
Received
(238 days to decision)
Product code
MIG Strip, Test Isoniazid
Device class
Unclassified
Review panel
Unknown
Applicant
Dynagen, Inc. 99 Erie St.,, Cambridge MA
510(k) summary
Statement
Third party review
No

Clearances, product code MIG

Trailing 12 months

FDA records hold no clearances under product code MIG in the trailing twelve months.

FDA records show no clearances under product code MIG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MIG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260