COAGULATION REFERENCE PLASMA, ABNORMAL— 510(k) K904073

Name: FDA 510(k) clearance K904073
Creator: U.S. Food and Drug Administration
Published: 1990-10-22

Substantially Equivalent

Medi-Tech, Inc.

FDA 510(k) clearance K904073 for COAGULATION REFERENCE PLASMA, ABNORMAL, Substantially Equivalent on 1990-10-22. Applicant: Medi-Tech, Inc.. Device class: 2.

Clearance details

Applicant: Medi-Tech, Inc.
Product code: Code GGC
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1990-09-05
Decision date: 1990-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

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