GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION— 510(k) K934900

Name: FDA 510(k) clearance K934900
Creator: U.S. Food and Drug Administration
Published: 1993-12-07

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K934900 for GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION, Substantially Equivalent on 1993-12-07. Applicant: Heraeus Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code CFR
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 1993-10-13
Decision date: 1993-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mishawaka, IN, US

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