DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI— 510(k) K823213

Name: FDA 510(k) clearance K823213
Creator: U.S. Food and Drug Administration
Published: 1982-11-22

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K823213 for DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI, Substantially Equivalent on 1982-11-22. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1982-10-28
Decision date: 1982-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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