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
|
|
Correspondent Contact |
Roger De Bock |
Regulation Number | 862.3650
|
Classification Product Code |
|
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
|
|
|