LA POSITIVE CONTROL PLASMA— 510(k) K961370

Name: FDA 510(k) clearance K961370
Creator: U.S. Food and Drug Administration
Published: 1996-05-24

Substantially Equivalent

Medical Diagnostic Technologies, Inc.

FDA 510(k) clearance K961370 for LA POSITIVE CONTROL PLASMA, Substantially Equivalent on 1996-05-24. Applicant: Medical Diagnostic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Medical Diagnostic Technologies, Inc.
Product code: Code GGC
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1996-04-09
Decision date: 1996-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

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