QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA


Device Classification Name

gas chromatography, methamphetamine

510(k) Number K080381
Device Name QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA
Applicant
QUEST DIAGNOSTICS, INC.
10101 renner blvd.
lenexa, 
KS 
66219 -9752

Applicant Contact liuming yu
Correspondent
QUEST DIAGNOSTICS, INC.
10101 renner blvd.
lenexa, 
KS 
66219 -9752

Correspodent Contact liuming yu
Regulation Number 862.3610
Classification Product Code
LAF  
Date Received 02/13/2008
Decision Date 06/25/2008
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