510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896686Substantially Equivalent

Amresco Creatinine Reagent #4316100

American Research Products Co., Solon OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896686 is the FDA 510(k) clearance record for AMRESCO CREATININE REAGENT #4316100, a class II device, cleared for American Research Products Co. on under FDA product code CGX (Alkaline Picrate, Colorimetry, Creatinine). FDA records list 56 510(k) clearances for American Research Products Co., from to . As of , FDA records show no recalls naming K896686.

Clearance record

Decision date
Received
(72 days to decision)
Product code
CGX Alkaline Picrate, Colorimetry, Creatinine
Regulation
21 CFR 862.1225
Device class
Class II
Review panel
Clinical Chemistry
Applicant
American Research Products Co. 30175 Solon Industrial Pkwy., Solon OH
Third party review
No

Clearances, product code CGX

Trailing 12 months
2 clearances under product code CGX in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CGX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260