Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Tianjin New Bay Bioresearch Co., Ltd. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
195 daysmedian FDA review time
303 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130275 | QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST | Tianjin New Bay Bioresearch Co., Ltd. | 2013-09-26 | 234 | 0 |
| K122064 | FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE | Tianjin New Bay Bioresearch Co., Ltd. | 2013-05-07 | 298 | 0 |
| K112449 | QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST | Tianjin New Bay Bioresearch Co., Ltd. | 2012-09-24 | 396 | 0 |
| K071489 | HOMECHECK MULTIPLE DRUG CUP TEST | Tianjin New Bay Bioresearch Co., Ltd. | 2008-03-28 | 303 | 0 |
| K073431 | FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR | Tianjin New Bay Bioresearch Co., Ltd. | 2008-01-14 | 39 | 2 |
| K061617 | FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST | Tianjin New Bay Bioresearch Co., Ltd. | 2006-11-22 | 166 | 0 |
| K052520 | RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST D | Tianjin New Bay Bioresearch Co., Ltd. | 2006-04-24 | 222 | 0 |
| K052882 | FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CU | Tianjin New Bay Bioresearch Co., Ltd. | 2006-02-15 | 126 | 0 |
| K052208 | GLUCOSE PILOT | Tianjin New Bay Bioresearch Co., Ltd. | 2005-12-09 | 119 | 0 |
| K042988 | RAPID ONE STEP BUPRENORPHINE TEST CARD | Tianjin New Bay Bioresearch Co., Ltd. | 2005-05-12 | 195 | 0 |
| K042990 | FOR SURE ONE STEP BUPRENORPHINE TEST STRIP | Tianjin New Bay Bioresearch Co., Ltd. | 2005-05-10 | 193 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda