Tianjin New Bay Bioresearch Co., Ltd.
Carlsbad, CA, US
Tianjin New Bay Bioresearch Co., Ltd. appears in FDA device records in Carlsbad, CA. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Tianjin New Bay Bioresearch Co., Ltd. between 2005 and 2013. The busiest year on record is 2005, with 3. The most recent is 2013, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 3 |
| 2006 | 3 |
| 2008 | 2 |
| 2012 | 1 |
| 2013 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K130275 | QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST | DJG | Substantially Equivalent | |
| K122064 | FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE | DJG | Substantially Equivalent | |
| K112449 | QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST | LCX | Substantially Equivalent | |
| K071489 | HOMECHECK MULTIPLE DRUG CUP TEST | DKZ | Substantially Equivalent | |
| K073431 | FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T | KHE | Substantially Equivalent | |
| K061617 | FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST | DKZ | Substantially Equivalent | |
| K052520 | RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC | DJG | Substantially Equivalent | |
| K052882 | FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE | DKZ | Substantially Equivalent | |
| K052208 | GLUCOSE PILOT | NBW | Substantially Equivalent | |
| K042988 | RAPID ONE STEP BUPRENORPHINE TEST CARD | DJG | Substantially Equivalent | |
| K042990 | FOR SURE ONE STEP BUPRENORPHINE TEST STRIP | DJG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain