PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)


Device Classification Name

enzyme immunoassay, propoxyphene

510(k) Number K023795
Device Name PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)
Original Applicant
Lin-Zhi International, Inc.
2391 zanker rd., suite 340
san jose, 
CA 
95131 -1124

Original Contact chiu chin chang
Regulation Number 862.3700
Classification Product Code
JXN  
Date Received 11/13/2002
Decision Date 01/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No