510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091544Substantially Equivalent

S-Test Lactate Dehydrogenase (Ld), Model Rc 0017

Alfa Wassermann, West Caldwell NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091544 is the FDA 510(k) clearance record for S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017, a class II device, cleared for Alfa Wassermann, Inc. on under FDA product code CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase). FDA records list 9 510(k) clearances for Alfa Wassermann, Inc., from to . As of , FDA records show no recalls naming K091544.

Clearance record

Decision date
Received
(105 days to decision)
Product code
CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Regulation
21 CFR 862.1440
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Alfa Wassermann, Inc. 4 Henderson Dr., West Caldwell NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CFJ

Trailing 12 months

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

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