QAB2A IGM ELISA KIT HRP


Device Classification Name

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

510(k) Number K021610
Device Name QAB2A IGM ELISA KIT HRP
Original Applicant
CHESHIRE DIAGNOSTICS LTD.
7 elm st.
ellesmere port
cheshire, 

GB

ch65 2au

Original Contact neil b stringer
Regulation Number 866.5660
Classification Product Code
MSV  
Date Received 05/16/2002
Decision Date 07/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No