510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942958Substantially Equivalent

Creatine Kinase Mb Determination (UV)

Biochemical Trade, Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942958 is the FDA 510(k) clearance record for CREATINE KINASE MB DETERMINATION (UV), a class II device, cleared for Biochemical Trade, Inc. on under FDA product code JHW (U.V. Method, Cpk Isoenzymes). FDA records list 20 510(k) clearances for Biochemical Trade, Inc., from to . As of , FDA records show one recall naming K942958.

Clearance record

Decision date
Received
(151 days to decision)
Product code
JHW U.V. Method, Cpk Isoenzymes
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Biochemical Trade, Inc. 7522 NW 55th St., Miami FL
510(k) summary
Statement
Third party review
No

Clearances, product code JHW

Trailing 12 months

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

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