LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444


Device Classification Name

drug mixture control materials

510(k) Number K021384
Device Name LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444
Original Applicant
BIO-RAD
9500 jeronimo rd.
irvine, 
CA 
92618 -2017

Original Contact elizabeth platt
Regulation Number 862.3280
Classification Product Code
DIF  
Date Received 05/02/2002
Decision Date 05/29/2002
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