510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K942773Substantially Equivalent

Ck-Mb Assay, Catalogue Number 317-10

Sekisui Diagnostics P.E.I. Inc., Charlottetown, P.E.I., CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942773 is the FDA 510(k) clearance record for CK-MB ASSAY, CATALOGUE NUMBER 317-10, a class II device, cleared for Diagnostic Chemicals , Ltd. on under FDA product code CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes). FDA records list 72 510(k) clearances for Sekisui Diagnostics P.E.I. Inc., from to . As of , FDA records show no recalls naming K942773.

Clearance record

Decision date
Received
(72 days to decision)
Product code
CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Diagnostic Chemicals , Ltd. West Royalty Industrial Park,, Charlottetown, P.E.I., CA
510(k) summary
Statement
Third party review
No

Clearances, product code CGS

Trailing 12 months

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

FDA records show no clearances under product code CGS in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CGS, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260