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
K880654Substantially Equivalent

Amresco Liquizyme Glucose/bun Standard 0124, 0200

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

K880654 is the FDA 510(k) clearance record for AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200, a class II device, cleared for American Research Products Co. on under FDA product code JIW (Calibrator, Surrogate). FDA records list 56 510(k) clearances for American Research Products Co., from to . As of , FDA records show no recalls naming K880654.

Clearance record

Decision date
Received
(111 days to decision)
Product code
JIW Calibrator, Surrogate
Regulation
21 CFR 862.1150
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 JIW

Trailing 12 months

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

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