BIO SET TM SUBSTRATE CALIBRATORS— 510(k) K810963

Name: FDA 510(k) clearance K810963
Creator: U.S. Food and Drug Administration
Published: 1981-04-17

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K810963 for BIO SET TM SUBSTRATE CALIBRATORS, Substantially Equivalent on 1981-04-17. 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: 1981-04-08
Decision date: 1981-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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