AMYLASE— 510(k) K980013

Substantially Equivalent

Ac Biochemicals, Inc.

FDA 510(k) clearance K980013 for AMYLASE, Substantially Equivalent on 1998-02-04. Applicant: Ac Biochemicals, Inc..

Clearance details

Applicant: Ac Biochemicals, Inc.
Product code: Code CIJ
Advisory panel: Clinical Chemistry
Date received: 1998-01-02
Decision date: 1998-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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