QACA IGG/IGM ELISA KIT HRP


Device Classification Name

system, test, anticardiolipin immunological

510(k) Number K021192
Device Name QACA IGG/IGM ELISA KIT HRP
Original Applicant
CHESHIRE DIAGNOSTICS LTD.
7 elm st.
ellesmere port, 

GB

ch65 2au

Original Contact neil b stringer
Regulation Number 866.5660
Classification Product Code
MID  
Date Received 04/15/2002
Decision Date 05/16/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No