IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA


Device Classification Name

system,test,antibodies,b2 – glycoprotein i (b2 – gpi)

510(k) Number K030701
Device Name IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA
Applicant
IMMCO DIAGNOSTICS, INC.
60 pineview dr.
buffalo, 
NY 
14228

Applicant Contact kevin j lawson
Correspondent
IMMCO DIAGNOSTICS, INC.
60 pineview dr.
buffalo, 
NY 
14228

Correspodent Contact kevin j lawson
Regulation Number 866.5660
Classification Product Code
MSV  
Date Received 03/06/2003
Decision Date 09/09/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No