510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884226Substantially Equivalent

Amylase Reagent Kit for Astra Systems

A-Kem, Inc., Clifton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884226 is the FDA 510(k) clearance record for AMYLASE REAGENT KIT FOR ASTRA SYSTEMS, a class II device, cleared for A-Kem, Inc. on under FDA product code CJA (Amyloclastic, Amylase). FDA records list 13 510(k) clearances for A-Kem, Inc., from to . As of , FDA records show no recalls naming K884226.

Clearance record

Decision date
Received
(64 days to decision)
Product code
CJA Amyloclastic, Amylase
Regulation
21 CFR 862.1070
Device class
Class II
Review panel
Clinical Chemistry
Applicant
A-Kem, Inc. P.O. Box 1589, Clifton NJ
Third party review
No

Clearances, product code CJA

Trailing 12 months

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

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