510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K873117Substantially Equivalent

Biotrol Glucose Enzymatique Color Reagent

Biotrol, USA, Inc., Berwyn PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K873117 is the FDA 510(k) clearance record for BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT, a class II device, cleared for Biotrol, USA, Inc. on under FDA product code CGA (Glucose Oxidase, Glucose). FDA records list 46 510(k) clearances for Biotrol, USA, Inc., from to . As of , FDA records show no recalls naming K873117.

Clearance record

Decision date
Received
(21 days to decision)
Product code
CGA Glucose Oxidase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Biotrol, USA, Inc. P.O. Box 562, Berwyn PA
Third party review
No

Clearances, product code CGA

Trailing 12 months
1 clearance under product code CGA in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CGA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260