FDA 510(k) Applications Submitted by Tianjin New Bay Bioresearch Co., Ltd.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K073431 |
12/06/2007 |
FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T |
Tianjin New Bay Bioresearch Co., Ltd. |
| K071489 |
05/30/2007 |
HOMECHECK MULTIPLE DRUG CUP TEST |
Tianjin New Bay Bioresearch Co., Ltd. |
| K112449 |
08/25/2011 |
QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST |
Tianjin New Bay Bioresearch Co., Ltd. |
| K052208 |
08/12/2005 |
GLUCOSE PILOT |
Tianjin New Bay Bioresearch Co., Ltd. |
| K052520 |
09/14/2005 |
RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC |
Tianjin New Bay Bioresearch Co., Ltd. |
| K052882 |
10/12/2005 |
FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE |
Tianjin New Bay Bioresearch Co., Ltd. |
| K042988 |
10/29/2004 |
RAPID ONE STEP BUPRENORPHINE TEST CARD |
Tianjin New Bay Bioresearch Co., Ltd. |
| K042990 |
10/29/2004 |
FOR SURE ONE STEP BUPRENORPHINE TEST STRIP |
Tianjin New Bay Bioresearch Co., Ltd. |
| K061617 |
06/09/2006 |
FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST |
Tianjin New Bay Bioresearch Co., Ltd. |
| K130275 |
02/04/2013 |
QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST |
Tianjin New Bay Bioresearch Co., Ltd. |
| K122064 |
07/13/2012 |
FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE |
Tianjin New Bay Bioresearch Co., Ltd. |
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