GENERAL DIAGNOSTICS COAG-A-MATE XC— 510(k) K852843

Name: FDA 510(k) clearance K852843
Creator: U.S. Food and Drug Administration
Published: 1985-08-13

Substantially Equivalent

Warner-Lambert Co.

FDA 510(k) clearance K852843 for GENERAL DIAGNOSTICS COAG-A-MATE XC, Substantially Equivalent on 1985-08-13. Applicant: Warner-Lambert Co.. Device class: 1.

Clearance details

Applicant: Warner-Lambert Co.
Product code: Code KQC
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1985-07-05
Decision date: 1985-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morris Plains, NJ, US

Download summary PDF View on FDA.gov ↗

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