510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K954537Substantially Equivalent

Olympus C-Reactive Protein Immunoturbidimetric Reagent

OLYMPUS Corporation of the Americas, Melville NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954537 is the FDA 510(k) clearance record for OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT, a class II device, cleared for Olympus America, Inc. on under FDA product code DCN (System, Test, C-Reactive Protein). FDA records list 150 510(k) clearances for OLYMPUS Corporation of the Americas, from to . As of , FDA records show no recalls naming K954537.

Clearance record

Decision date
Received
(138 days to decision)
Product code
DCN System, Test, C-Reactive Protein
Regulation
21 CFR 866.5270
Device class
Class II
Review panel
Immunology
Applicant
Olympus America, Inc. Two Corporate Center Dr., Melville NY
510(k) summary
Statement
Third party review
No

Clearances, product code DCN

Trailing 12 months

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

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