ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM


the company

Device Classification Name

system, test, anticardiolipin immunological

510(k) Number K003069
Device Name ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
Original Applicant
QUEST INTL., INC.
1938 n.e. 148th terr.
north miami, 
FL 
33181

Original Contact robert a cort
Regulation Number 866.5660
Classification Product Code
MID  
Date Received 10/02/2000
Decision Date 11/27/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No