LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC


Device Classification Name

drug mixture control materials

510(k) Number K072721
Device Name LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC
Applicant
BIO-RAD, DIAGNOSTICS GRP.
9500 jeronimo rd.
irvine, 
CA 
92618 -2017

Applicant Contact elizabeth platt
Correspondent
BIO-RAD, DIAGNOSTICS GRP.
9500 jeronimo rd.
irvine, 
CA 
92618 -2017

Correspodent Contact elizabeth platt
Regulation Number 862.3280
Classification Product Code
DIF  
Date Received 09/26/2007
Decision Date 12/11/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No