510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K923412Substantially Equivalent

Olympus Lactate Dehydrogenase Reagent

Olympus Corp., Lake Success NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923412 is the FDA 510(k) clearance record for OLYMPUS LACTATE DEHYDROGENASE REAGENT, a class II device, cleared for Olympus Corp. on under FDA product code CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase). FDA records list 149 510(k) clearances for Olympus Corp., from to . As of , FDA records show no recalls naming K923412.

Clearance record

Decision date
Received
(70 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
Olympus Corp. 4 Nevada Dr., Lake Success NY
510(k) summary
Statement
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CFJ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260