510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903714Substantially Equivalent

E. Coli 0157 Latex Test

Pro-Lab, Inc., Round Rock TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903714 is the FDA 510(k) clearance record for E. COLI 0157 LATEX TEST, a class I device, cleared for Pro-Lab, Inc. on under FDA product code GNA (Antisera, All Types, Escherichia Coli). FDA records list 27 510(k) clearances for Pro-Lab, Inc., from to . As of , FDA records show no recalls naming K903714.

Clearance record

Decision date
Received
(163 days to decision)
Product code
GNA Antisera, All Types, Escherichia Coli
Regulation
21 CFR 866.3255
Device class
Class I
Review panel
Microbiology
Applicant
Pro-Lab, Inc. P.O. Box 503, Round Rock TX
Third party review
No

Clearances, product code GNA

Trailing 12 months

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

FDA records show no clearances under product code GNA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GNA, 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