AMYLASE— 510(k) K930678

Substantially Equivalent

Horizon Diagnostics, Inc.

FDA 510(k) clearance K930678 for AMYLASE, Substantially Equivalent on 1994-04-06. Applicant: Horizon Diagnostics, Inc..

Clearance details

Applicant: Horizon Diagnostics, Inc.
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 1993-02-09
Decision date: 1994-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

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