AMYLASE— 510(k) K812699

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K812699 for AMYLASE, Substantially Equivalent on 1981-10-06. Applicant: Pointe Scientific, Inc.,.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code KHM
Advisory panel: Clinical Chemistry
Date received: 1981-09-22
Decision date: 1981-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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