510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K872041Substantially Equivalent

Coulter Dart Ck-Mb Isoenzyme Reagent System

Coulter Electronics, Inc., Hialeah FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872041 is the FDA 510(k) clearance record for COULTER DART CK-MB ISOENZYME REAGENT SYSTEM, a class II device, cleared for Coulter Electronics, Inc. on under FDA product code JHT (Chromatographic Separation, Cpk Isoenzymes). FDA records list 101 510(k) clearances for Coulter Electronics, Inc., from to . As of , FDA records show no recalls naming K872041.

Clearance record

Decision date
Received
(112 days to decision)
Product code
JHT Chromatographic Separation, Cpk Isoenzymes
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Coulter Electronics, Inc. 440 W. 20 St., Hialeah FL
Third party review
No

Clearances, product code JHT

Trailing 12 months

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

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