FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE


Device Classification Name

enzyme immunoassay, opiates

510(k) Number K122064
Device Name FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE
Applicant
Tianjin New Bay Bioresearch Co., Ltd.
4455 murphy canyon rd
suite 204
san diego, 
CA 
92123

Applicant Contact roger de bock
Correspondent
Tianjin New Bay Bioresearch Co., Ltd.
4455 murphy canyon rd
suite 204
san diego, 
CA 
92123

Correspodent Contact roger de bock
Regulation Number 862.3650
Classification Product Code
DJG  
Date Received 07/13/2012
Decision Date 05/07/2013
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