510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K901500Substantially Equivalent

Chloride Reagent for the Au5000 Clinical Lab. Ana.

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

K901500 is the FDA 510(k) clearance record for CHLORIDE REAGENT FOR THE AU5000 CLINICAL LAB. ANA., a class II device, cleared for Olympus Corp. on under FDA product code CHJ (Mercuric Thiocyanate, Colorimetry, Chloride). FDA records list 149 510(k) clearances for Olympus Corp., from to . As of , FDA records show no recalls naming K901500.

Clearance record

Decision date
Received
(103 days to decision)
Product code
CHJ Mercuric Thiocyanate, Colorimetry, Chloride
Regulation
21 CFR 862.1170
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Olympus Corp. 4 Nevada Dr., Lake Success NY
Third party review
No

Clearances, product code CHJ

Trailing 12 months

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

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