510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070835Substantially Equivalent

Olympus Ck-Mb Reagent

Olympus Life & Material Science Europa GmbH (Irish, O'Callaghans Mills, Co. Clare, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070835 is the FDA 510(k) clearance record for OLYMPUS CK-MB REAGENT, a class II device, cleared for Olympus Life & Material Science Europa GmbH (Irish on under FDA product code JHY (Colorimetric Method, Cpk Or Isoenzymes). FDA records list 3 510(k) clearances for Olympus Life & Material Science Europa GmbH (Irish, from to . As of , FDA records show no recalls naming K070835.

Clearance record

Decision date
Received
(69 days to decision)
Product code
JHY Colorimetric Method, Cpk Or Isoenzymes
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Olympus Life & Material Science Europa GmbH (Irish Lismeehan, O'Callaghans Mills, Co. Clare, IE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JHY

Trailing 12 months

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

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