HARLECO BRAND CLINICARD LIPASE TEST SET— 510(k) K791922

Name: FDA 510(k) clearance K791922
Creator: U.S. Food and Drug Administration
Published: 1979-11-27

Substantially Equivalent

Dade, Baxter Travenol Diagnostics, Inc.

FDA 510(k) clearance K791922 for HARLECO BRAND CLINICARD LIPASE TEST SET, Substantially Equivalent on 1979-11-27. Applicant: Dade, Baxter Travenol Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Dade, Baxter Travenol Diagnostics, Inc.
Product code: Code CET
Device class: Class 1
Regulation: 21 CFR 862.1465
Advisory panel: Clinical Chemistry
Date received: 1979-09-26
Decision date: 1979-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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