THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS— 510(k) K961814

Name: FDA 510(k) clearance K961814
Creator: U.S. Food and Drug Administration
Published: 1996-08-13

Substantially Equivalent

Cardiovascular Diagnostics, Inc.

FDA 510(k) clearance K961814 for THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS, Substantially Equivalent on 1996-08-13. Applicant: Cardiovascular Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Cardiovascular Diagnostics, Inc.
Product code: Code GIZ
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1996-05-10
Decision date: 1996-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raleigh, NC, US

Download summary PDF View on FDA.gov ↗

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