OPIATE ENZYME IMMUNOASSAY


Device Classification Name

enzyme immunoassay, opiates

510(k) Number K110298
Device Name OPIATE ENZYME IMMUNOASSAY
Applicant
Lin-Zhi International, Inc.
670 almanor avenue
sunnyvale, 
CA 
94085

Applicant Contact bernice lin
Correspondent
Lin-Zhi International, Inc.
670 almanor avenue
sunnyvale, 
CA 
94085

Correspodent Contact bernice lin
Regulation Number 862.3650
Classification Product Code
DJG  
Date Received 02/01/2011
Decision Date 07/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No