510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971817Substantially Equivalent

Olympus Ck-Mb Reagent

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

K971817 is the FDA 510(k) clearance record for OLYMPUS CK-MB REAGENT, a class I device, cleared for Olympus America, Inc. on under FDA product code JLB (Atp And Creatine Kinase (Enzymatic), Creatine). FDA records list 150 510(k) clearances for OLYMPUS Corporation of the Americas, from to . As of , FDA records show no recalls naming K971817.

Clearance record

Decision date
Received
(26 days to decision)
Product code
JLB Atp And Creatine Kinase (Enzymatic), Creatine
Regulation
21 CFR 862.1210
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Olympus America, Inc. Two Corporate Center Dr., Melville NY
510(k) summary
Statement
Third party review
No

Clearances, product code JLB

Trailing 12 months

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

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