REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT


Device Classification Name

system, test, anticardiolipin immunological

510(k) Number K024196
Device Name REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
Original Applicant
CORGENIX, INC.
12061 tejon st.
westminster, 
CO 
80234

Original Contact nanci dexter
Regulation Number 866.5660
Classification Product Code
MID  
Date Received 12/20/2002
Decision Date 01/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No