PRECISET CHOLESTEROL HIGH PERFORM— 510(k) K832251

Name: FDA 510(k) clearance K832251
Creator: U.S. Food and Drug Administration
Published: 1983-08-24

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K832251 for PRECISET CHOLESTEROL HIGH PERFORM, Substantially Equivalent on 1983-08-24. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1983-07-11
Decision date: 1983-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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