REFLOTRON (R) AMYLASE— 510(k) K874704

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K874704 for REFLOTRON (R) AMYLASE, Substantially Equivalent on 1988-01-05. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 1987-11-19
Decision date: 1988-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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