METHADONE ENZYME IMMUNOASSAY


Device Classification Name

enzyme immunoassay, methadone

510(k) Number K023317
Device Name METHADONE ENZYME IMMUNOASSAY
Original Applicant
Lin-Zhi International, Inc.
2391 zanker rd., suite 340
san jose, 
CA 
95131 -1124

Original Contact chiu chin chang
Regulation Number 862.3620
Classification Product Code
DJR  
Date Received 10/03/2002
Decision Date 12/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No