APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT— 510(k) K900049

Name: FDA 510(k) clearance K900049
Creator: U.S. Food and Drug Administration
Published: 1990-01-25

Substantially Equivalent

Medical Diagnostic Technologies, Inc.

FDA 510(k) clearance K900049 for APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT, Substantially Equivalent on 1990-01-25. Applicant: Medical Diagnostic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Medical Diagnostic Technologies, Inc.
Product code: Code GFO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1990-01-03
Decision date: 1990-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

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