COAGULATION REFERENCE PLASMA, NORMAL— 510(k) K932145

Name: FDA 510(k) clearance K932145
Creator: U.S. Food and Drug Administration
Published: 1993-10-18

Substantially Equivalent

American Diagnostic Corp.

FDA 510(k) clearance K932145 for COAGULATION REFERENCE PLASMA, NORMAL, Substantially Equivalent on 1993-10-18. Applicant: American Diagnostic Corp.. Device class: 2.

Clearance details

Applicant: American Diagnostic Corp.
Product code: Code GIZ
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1993-05-04
Decision date: 1993-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwich, CT, US

Download summary PDF View on FDA.gov ↗

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