ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)

Device Classification Name

thin layer chromatography, metamphetamine

510(k) Number K033094
Device Name ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)
Applicant
Lin-Zhi International, Inc.
687 north pastoria ave.
sunnyvale, 
CA 
94085 -2917

Applicant Contact cheng-i lin
Correspondent
Lin-Zhi International, Inc.
687 north pastoria ave.
sunnyvale, 
CA 
94085 -2917

Correspodent Contact cheng-i lin
Regulation Number 862.3610
Classification Product Code
DJC  
Subsequent Product Codes
DLJ   LAS  
Date Received 09/29/2003
Decision Date 12/19/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No