COAGULATION REFERENCE PLASMA, NORMAL— 510(k) K905203

Name: FDA 510(k) clearance K905203
Creator: U.S. Food and Drug Administration
Published: 1990-12-28

Substantially Equivalent

Medical Diagnostic Technologies, Inc.

FDA 510(k) clearance K905203 for COAGULATION REFERENCE PLASMA, NORMAL, Substantially Equivalent on 1990-12-28. Applicant: Medical Diagnostic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Medical Diagnostic Technologies, Inc.
Product code: Code GIZ
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1990-11-20
Decision date: 1990-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

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