LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469


Device Classification Name

drug mixture control materials

510(k) Number K021415
Device Name LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469
Original Applicant
BIO-RAD
9500 jeronimo rd.
irvine, 
CA 
92618 -2017

Original Contact elizabeth plate
Regulation Number 862.3280
Classification Product Code
DIF  
Date Received 05/03/2002
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