SINGLE VIAL AMYLASE PNP TEST— 510(k) K823462

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K823462 for SINGLE VIAL AMYLASE PNP TEST, Substantially Equivalent on 1982-12-28. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 1982-11-19
Decision date: 1982-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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