GLUCOSE PROCEDURE, TEKPOINT DIRECT— 510(k) K770455

Name: FDA 510(k) clearance K770455
Creator: U.S. Food and Drug Administration
Published: 1977-05-03

Substantially Equivalent

Icn Pharmaceuticals, Inc.

FDA 510(k) clearance K770455 for GLUCOSE PROCEDURE, TEKPOINT DIRECT, Substantially Equivalent on 1977-05-03. Applicant: Icn Pharmaceuticals, Inc.. Device class: 2.

Clearance details

Applicant: Icn Pharmaceuticals, Inc.
Product code: Code CGE
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 1977-03-08
Decision date: 1977-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangeburg, NY, US

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