AMYLASE— 510(k) K910158

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K910158 for AMYLASE, Substantially Equivalent on 1991-04-30. Applicant: Pointe Scientific, Inc.,.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 1991-01-15
Decision date: 1991-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

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