510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933397Substantially Equivalent

Genzyme a-Amylase Test Reagent

Genzyme Corporation, Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933397 is the FDA 510(k) clearance record for GENZYME A-AMYLASE TEST REAGENT, a class II device, cleared for Genzyme Corp. on under FDA product code JFJ (Catalytic Methods, Amylase). FDA records list 33 510(k) clearances for Genzyme Corp., from to . As of , FDA records show no recalls naming K933397.

Clearance record

Decision date
Received
(108 days to decision)
Product code
JFJ Catalytic Methods, Amylase
Regulation
21 CFR 862.1070
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Genzyme Corp. One Kendall Sq., Cambridge MA
510(k) summary
Summary
Third party review
No

Clearances, product code JFJ

Trailing 12 months

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

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