Tianjin New Bay Bioresearch Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 11
- Inspections
- 1
- Compliance Actions
- 1
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K130275 | QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST | September 26, 2013 |
| K122064 | FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE | May 7, 2013 |
| K112449 | QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST | September 24, 2012 |
| K071489 | HOMECHECK MULTIPLE DRUG CUP TEST | March 28, 2008 |
| K073431 | FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFES | January 14, 2008 |
| K061617 | FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST | November 22, 2006 |
| K052520 | RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, | April 24, 2006 |
| K052882 | FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE | February 15, 2006 |
| K052208 | GLUCOSE PILOT | December 9, 2005 |
| K042988 | RAPID ONE STEP BUPRENORPHINE TEST CARD | May 12, 2005 |
| K042990 | FOR SURE ONE STEP BUPRENORPHINE TEST STRIP | May 10, 2005 |