DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA— 510(k) K935254

Name: FDA 510(k) clearance K935254
Creator: U.S. Food and Drug Administration
Published: 1994-09-19

Substantially Equivalent

American Diagnostica, Inc.

FDA 510(k) clearance K935254 for DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA, Substantially Equivalent on 1994-09-19. Applicant: American Diagnostica, Inc.. Device class: 2.

Clearance details

Applicant: American Diagnostica, Inc.
Product code: Code GIZ
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1993-11-01
Decision date: 1994-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwich, CT, US

Download summary PDF View on FDA.gov ↗

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