ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1)— 510(k) K895260

Name: FDA 510(k) clearance K895260
Creator: U.S. Food and Drug Administration
Published: 1989-10-06

Substantially Equivalent

Medical Diagnostic Technologies, Inc.

FDA 510(k) clearance K895260 for ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1), Substantially Equivalent on 1989-10-06. 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: 1989-08-22
Decision date: 1989-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

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