KING DIAGNOSTICS GLUCOSE-O TEST— 510(k) K811883

Name: FDA 510(k) clearance K811883
Creator: U.S. Food and Drug Administration
Published: 1981-07-23

Substantially Equivalent

King Diagnostics, Inc.

FDA 510(k) clearance K811883 for KING DIAGNOSTICS GLUCOSE-O TEST, Substantially Equivalent on 1981-07-23. Applicant: King Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: King Diagnostics, Inc.
Product code: Code CGE
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 1981-07-01
Decision date: 1981-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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