510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924339Substantially Equivalent

Olympus Amylase Reagent

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

K924339 is the FDA 510(k) clearance record for OLYMPUS AMYLASE REAGENT, a class II device, cleared for Olympus Corp. on under FDA product code CIW (Starch-Dye Bound Polymer, Amylase). FDA records list 149 510(k) clearances for Olympus Corp., from to . As of , FDA records show no recalls naming K924339.

Clearance record

Decision date
Received
(52 days to decision)
Product code
CIW Starch-Dye Bound Polymer, Amylase
Regulation
21 CFR 862.1070
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 CIW

Trailing 12 months

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

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