PLATELET AGGREGATION REAGENTS— 510(k) K910286

Name: FDA 510(k) clearance K910286
Creator: U.S. Food and Drug Administration
Published: 1991-03-19

Substantially Equivalent

Medical Diagnostic Technologies, Inc.

FDA 510(k) clearance K910286 for PLATELET AGGREGATION REAGENTS, Substantially Equivalent on 1991-03-19. Applicant: Medical Diagnostic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Medical Diagnostic Technologies, Inc.
Product code: Product code GHR
Device class: Class 2
Regulation: 21 CFR 864.5700
Advisory panel: Hematology
Date received: 1991-01-22
Decision date: 1991-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

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