CREATINE KINASE-MB (CK-MB) REAGENT SET— 510(k) K935463

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K935463 for CREATINE KINASE-MB (CK-MB) REAGENT SET, Substantially Equivalent on 1994-01-11. Applicant: Pointe Scientific, Inc.,.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code CGS
Advisory panel: Clinical Chemistry
Date received: 1993-11-12
Decision date: 1994-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

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