510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945083Substantially Equivalent

Access Ck-Mb Reagents

Bio-Rad Laboratories Inc., Chaska MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945083 is the FDA 510(k) clearance record for ACCESS CK-MB REAGENTS, a class II device, cleared for Bio-Rad Laboratories, Inc. on under FDA product code JHS (Differential Rate Kinetic Method, Cpk Or Isoenzymes). FDA records list 128 510(k) clearances for Bio-Rad Laboratories, Inc., from to . As of , FDA records show no recalls naming K945083.

Clearance record

Decision date
Received
(35 days to decision)
Product code
JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Bio-Rad Laboratories, Inc. 1000 Lake Hazeltine Dr., Chaska MN
510(k) summary
Summary
Third party review
No

Clearances, product code JHS

Trailing 12 months

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

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