510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191296Substantially Equivalent

Pointe Scientific Creatinine Kinase (CK) Reagent Set

Medtest DX, Lincoln Park MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191296 is the FDA 510(k) clearance record for Pointe Scientific Creatinine Kinase (CK) Reagent Set, a class II device, cleared for Medtest DX on under FDA product code CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes). FDA records list 2 510(k) clearances for Medtest DX, from to . As of , FDA records show no recalls naming K191296.

Clearance record

Decision date
Received
(455 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
Medtest DX 5449 Research Dr., Lincoln Park MI
510(k) summary
Summary PDF
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