LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)


Device Classification Name

drug mixture control materials

510(k) Number K033924
Device Name LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)
Applicant
BIO-RAD LABORATORIES, INC.
9500 jeronimo rd.
irvine, 
CA 
92618 -2017

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

Correspodent Contact elizabeth platt
Regulation Number 862.3280
Classification Product Code
DIF  
Date Received 12/18/2003
Decision Date 02/03/2004
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