GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL— 510(k) K833352

Name: FDA 510(k) clearance K833352
Creator: U.S. Food and Drug Administration
Published: 1983-11-03

Substantially Equivalent

Warner-Lambert Co.

FDA 510(k) clearance K833352 for GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL, Substantially Equivalent on 1983-11-03. Applicant: Warner-Lambert Co.. Device class: 2.

Clearance details

Applicant: Warner-Lambert Co.
Product code: Code GIL
Device class: Class 2
Regulation: 21 CFR 864.7340
Advisory panel: Hematology
Date received: 1983-09-28
Decision date: 1983-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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