DIRECT GLUCOSE REAGENT SET— 510(k) K821198

Name: FDA 510(k) clearance K821198
Creator: U.S. Food and Drug Administration
Published: 1982-07-13

Substantially Equivalent

Omega Medical Electronics

FDA 510(k) clearance K821198 for DIRECT GLUCOSE REAGENT SET, Substantially Equivalent on 1982-07-13. Applicant: Omega Medical Electronics. Device class: 2.

Clearance details

Applicant: Omega Medical Electronics
Product code: Code CGE
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 1982-04-27
Decision date: 1982-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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