510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860663Substantially Equivalent

Amresco Flow Pac Creatine Phosphokinase Reagent

Amresco, Inc., Solon OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860663 is the FDA 510(k) clearance record for AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT, a class II device, cleared for Amresco, Inc. on under FDA product code JHY (Colorimetric Method, Cpk Or Isoenzymes). FDA records list 39 510(k) clearances for Amresco, Inc., from to . As of , FDA records show no recalls naming K860663.

Clearance record

Decision date
Received
(46 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
Amresco, Inc. 30175 Solon Industrial Pkwy., Solon OH
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