CREATINE KINASE (CK) REAGENT SET— 510(k) K930660

Name: FDA 510(k) clearance K930660
Creator: U.S. Food and Drug Administration
Published: 1993-03-29

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K930660 for CREATINE KINASE (CK) REAGENT SET, Substantially Equivalent on 1993-03-29. Applicant: Pointe Scientific, Inc.,. Device class: 2.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1993-02-09
Decision date: 1993-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

Download summary PDF View on FDA.gov ↗

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K070207 — MULTI-ANALYTE CHEMISTRY CALIBRATOR2007-04-13
K070504 — AMMONIA/ALCOHOL CONTROL SET2007-04-11

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