GILUCOCHEK REFLECTANCE METER— 510(k) K810665

Substantially Equivalent

Lifescan, Inc.

FDA 510(k) clearance K810665 for GILUCOCHEK REFLECTANCE METER, Substantially Equivalent on 1981-04-17. Applicant: Lifescan, Inc.. Device class: 1.

Clearance details

Applicant: Lifescan, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1981-03-11
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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Data sourced from openFDA. This site is unofficial and independent of the FDA.