510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K903194Substantially Equivalent

Reditest Strep a Test Kit

Boehringer Mannheim Corp., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903194 is the FDA 510(k) clearance record for REDITEST STREP A TEST KIT, a class I device, cleared for Boehringer Mannheim Corp. on under FDA product code GTZ (Antisera, All Groups, Streptococcus Spp.). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show no recalls naming K903194.

Clearance record

Decision date
Received
(34 days to decision)
Product code
GTZ Antisera, All Groups, Streptococcus Spp.
Regulation
21 CFR 866.3740
Device class
Class I
Review panel
Microbiology
Applicant
Boehringer Mannheim Corp. 9115 Hague Rd., Indianapolis IN
Third party review
No

Clearances, product code GTZ

Trailing 12 months

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

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