COAG-1 APTT TEST CARD— 510(k) K891015

Name: FDA 510(k) clearance K891015
Creator: U.S. Food and Drug Administration
Published: 1989-05-22

Substantially Equivalent

Cardiovascular Diagnostic Services

FDA 510(k) clearance K891015 for COAG-1 APTT TEST CARD, Substantially Equivalent on 1989-05-22. Applicant: Cardiovascular Diagnostic Services. Device class: 2.

Clearance details

Applicant: Cardiovascular Diagnostic Services
Product code: Code GFO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1989-02-28
Decision date: 1989-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Park, NC, US

Download summary PDF View on FDA.gov ↗

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