Tianjin New Bay Bioresearch Co., Ltd.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Tianjin New Bay Bioresearch Co., Ltd.” (first 2005, latest 2013), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 195 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 396 |
| 2013 | 2 | 266 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | 5 | 5 |
| DKZ | Enzyme Immunoassay, Amphetamine | 3 | 3 |
| KHE | Reagent, Occult Blood | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
| NBW | System, Test, Blood Glucose, Over The Counter | 1 | 1 |
Review panels
- Clinical Toxicology (8)
- Clinical Chemistry (2)
- Hematology (1)
Most recent Tianjin New Bay Bioresearch Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130275 | QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST | DJG | 2013-09-26 | 234 |
| K122064 | FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE | DJG | 2013-05-07 | 298 |
| K112449 | QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST | LCX | 2012-09-24 | 396 |
| K071489 | HOMECHECK MULTIPLE DRUG CUP TEST | DKZ | 2008-03-28 | 303 |
| K073431 | FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T | KHE | 2008-01-14 | 39 |
| K061617 | FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST | DKZ | 2006-11-22 | 166 |
| K052520 | RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC | DJG | 2006-04-24 | 222 |
| K052882 | FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE | DKZ | 2006-02-15 | 126 |
| K052208 | GLUCOSE PILOT | NBW | 2005-12-09 | 119 |
| K042988 | RAPID ONE STEP BUPRENORPHINE TEST CARD | DJG | 2005-05-12 | 195 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tianjin New Bay Bioresearch Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Tianjin Huahong Technology Co., Ltd. (16 510(k)s)
- Tianjin Empecs Medical Device Co., Ltd. (4 510(k)s)
- Tianjin Medis Medical Device Co., Ltd. (3 510(k)s)
- Tianjin Walkman Biomaterial Co., Ltd. (3 510(k)s)
- Tianjin Zhengtian Medical Instrument Co., Ltd. (3 510(k)s)
- Tianjin Aoshang Outdoor Equipment Co., Ltd. (2 510(k)s)
- Tianjin Rilifine Medical Device Co., Ltd. (2 510(k)s)
- Tianjin Uwell Medical Device Manufacturing Co., Ltd. (2 510(k)s)
- Tianjin Mastervision Technology Co., Ltd. (1 510(k)s)
- Tianjin Human-Care Latex Corporation (1 510(k)s)
- Tianjin Kepler Vehicle Industry Co. , Ltd. (1 510(k)s)
- Tianjin Medis International Trade Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tianjin New Bay Bioresearch Co., Ltd.?
FDA lists 11 510(k) clearances under the applicant name “Tianjin New Bay Bioresearch Co., Ltd.” (first 2005, latest 2013), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tianjin New Bay Bioresearch Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tianjin New Bay Bioresearch Co., Ltd. is 195 days.
Which FDA product codes appear under Tianjin New Bay Bioresearch Co., Ltd.?
The most frequent FDA product codes under this applicant name are DJG (Enzyme Immunoassay, Opiates, 5); DKZ (Enzyme Immunoassay, Amphetamine, 3); KHE (Reagent, Occult Blood, 1).
Next steps
- See all 11 Tianjin New Bay Bioresearch Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DJG, Tianjin New Bay Bioresearch Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.