REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001


Device Classification Name

system, test, anticardiolipin immunological

510(k) Number K022992
Device Name REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001
Original Applicant
CORGENIX, INC.
12061 tejon st.
westminster, 
CO 
80234

Original Contact nanci dexter
Regulation Number 866.5660
Classification Product Code
MID  
Date Received 09/09/2002
Decision Date 09/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No