Cleared Traditional

Pointe Scientific Creatinine Kinase (CK) Reagent Set

K191296 · Medtest DX · Chemistry
Aug 2020
Decision
455d
Days
Class 2
Risk

About This 510(k) Submission

K191296 is an FDA 510(k) clearance for the Pointe Scientific Creatinine Kinase (CK) Reagent Set, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Medtest DX (Lincoln Park, US). The FDA issued a Cleared decision on August 11, 2020, 455 days after receiving the submission on May 14, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K191296 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2019
Decision Date August 11, 2020
Days to Decision 455 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGS — Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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