UNITEST AMYLASE— 510(k) K782032

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K782032 for UNITEST AMYLASE, Substantially Equivalent on 1979-03-02. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code CIW
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1978-12-06
Decision date: 1979-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.