510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132571Substantially Equivalent

Elecsys Ck-Mb Stat Immunoassay, Elecsys Ck-Mb Immunoassay

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132571 is the FDA 510(k) clearance record for ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY, a class II device, cleared for Roche Diagnostics on under FDA product code JHY (Colorimetric Method, Cpk Or Isoenzymes). FDA records list 465 510(k) clearances for Roche Diagnostics, from to . As of , FDA records show no recalls naming K132571.

Clearance record

Decision date
Received
(64 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
Roche Diagnostics 9115 Hague Rd., Indianapolis IN
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