510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K852483Substantially Equivalent

Systemate Ck-Mb(nac-Activated) Item No. 67205

Em Diagnostic Systems, Inc., Gibbstown NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852483 is the FDA 510(k) clearance record for SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205, a class II device, cleared for Em Diagnostic Systems, Inc. on under FDA product code CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes). FDA records list 288 510(k) clearances for Em Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K852483.

Clearance record

Decision date
Received
(31 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
Em Diagnostic Systems, Inc. 480 Democrat Rd., Gibbstown NJ
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CGS, 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