LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL


Device Classification Name

enzyme immunoassay, cannabinoids

510(k) Number K110239
Device Name LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL
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 862.3870
Classification Product Code
LDJ  
Subsequent Product Codes
DLJ   LAS  
Date Received 01/26/2011
Decision Date 06/23/2011
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