QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)


Device Classification Name

enzyme immunoassay, amphetamine

510(k) Number K051161
Device Name QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)
Applicant
QUEST DIAGNOSTICS, INC.
4230 burnham ave.
las vegas, 
NV 
89119 -5410

Applicant Contact james bourland
Correspondent
QUEST DIAGNOSTICS, INC.
4230 burnham ave.
las vegas, 
NV 
89119 -5410

Correspodent Contact james bourland
Regulation Number 862.3100
Classification Product Code
DKZ  
Date Received 05/05/2005
Decision Date 11/22/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No