LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439


Device Classification Name

drug mixture control materials

510(k) Number K022707
Device Name LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439
Original Applicant
BIO-RAD
9500 jeronimo rd.
irvine, 
CA 
92618

Original Contact elizabeth platt
Regulation Number 862.3280
Classification Product Code
DIF  
Date Received 08/14/2002
Decision Date 08/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No