BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS


Device Classification Name

enzyme immunoassay, opiates

510(k) Number K081008
Device Name BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS
Applicant
Lin-Zhi International, Inc.
687 north pastoria ave.
sunnyvale, 
CA 
94085 -2917

Applicant Contact marie lin
Correspondent
Lin-Zhi International, Inc.
687 north pastoria ave.
sunnyvale, 
CA 
94085 -2917

Correspodent Contact marie lin
Regulation Number 862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DLJ   LAS  
Date Received 04/10/2008
Decision Date 12/22/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls