CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071


Device Classification Name

enzyme immunoassay, cannabinoids

510(k) Number K021887
Device Name CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071
Original Applicant
Lin-Zhi International, Inc.
2391 zanker rd., suite 340
san jose, 
CA 
95131 -1124

Original Contact chiu chin chang
Regulation Number 862.3870
Classification Product Code
LDJ  
Date Received 06/07/2002
Decision Date 08/15/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No