SPECIAL CONTROL SERUM FOR HDL-CHOLES— 510(k) K823196

Name: FDA 510(k) clearance K823196
Creator: U.S. Food and Drug Administration
Published: 1982-11-29

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K823196 for SPECIAL CONTROL SERUM FOR HDL-CHOLES, Substantially Equivalent on 1982-11-29. Applicant: Boehringer Mannheim Corp.. Device class: 1.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JJK
Device class: Class 1
Regulation: 21 CFR 862.2720
Advisory panel: Clinical Chemistry
Date received: 1982-10-26
Decision date: 1982-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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