80 MG/DL GLUCOSE CONTROL— 510(k) K844581

Name: FDA 510(k) clearance K844581
Creator: U.S. Food and Drug Administration
Published: 1984-12-12

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K844581 for 80 MG/DL GLUCOSE CONTROL, Substantially Equivalent on 1984-12-12. 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: 1984-11-23
Decision date: 1984-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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