AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR— 510(k) K981978

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K981978 for AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR, Substantially Equivalent on 1998-07-22. Applicant: Pointe Scientific, Inc.,.

Clearance details

Applicant
Pointe Scientific, Inc.,
Product code
Code MRR
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lincoln Park, MI, US
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