Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Syntron Bioresearch, Inc. — Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
239 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993490 | QUICKSTRIP ONE STEP OPIATES TEST | Syntron Bioresearch, Inc. | 1999-10-29 | 14 | 0 |
| K993491 | QUICKPAC II ONE STEP OPIATES TEST | Syntron Bioresearch, Inc. | 1999-10-29 | 14 | 0 |
| K992990 | QUICKPAC II ONE STEP COCAINE TEST | Syntron Bioresearch, Inc. | 1999-09-20 | 13 | 0 |
| K992748 | DRUGCHECK X MULTIDRUG SCREENING DEVICE | Syntron Bioresearch, Inc. | 1999-09-02 | 17 | 0 |
| K992207 | QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABO | Syntron Bioresearch, Inc. | 1999-07-22 | 22 | 0 |
| K990325 | QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE | Syntron Bioresearch, Inc. | 1999-06-24 | 142 | 0 |
| K983113 | BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT | Syntron Bioresearch, Inc. | 1998-11-18 | 75 | 0 |
| K981292 | QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST | Syntron Bioresearch, Inc. | 1998-05-26 | 47 | 0 |
| K981019 | QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST | Syntron Bioresearch, Inc. | 1998-05-07 | 50 | 0 |
| K980349 | QUICKPAC II ONE STEP BARBITURATE TEST | Syntron Bioresearch, Inc. | 1998-03-03 | 34 | 0 |
| K974712 | QUIKSTRIP ONE STEP BARBITURATE TEST | Syntron Bioresearch, Inc. | 1998-02-12 | 57 | 0 |
| K963654 | QUIKSTRIP ONESTEP MARIJUANA (THC) TEST | Syntron Bioresearch, Inc. | 1997-02-28 | 169 | 0 |
| K963341 | MIDSTREAM ONESTEP PREGNANCY HOME TEST | Syntron Bioresearch, Inc. | 1996-12-02 | 98 | 0 |
| K960117 | PLATFORM ONESTEP PREGNANCY HOME TEST | Syntron Bioresearch, Inc. | 1996-03-19 | 68 | 0 |
| K935475 | QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU | Syntron Bioresearch, Inc. | 1995-08-30 | 653 | 0 |
| K935554 | QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY | Syntron Bioresearch, Inc. | 1995-08-30 | 651 | 0 |
| K951538 | BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT | Syntron Bioresearch, Inc. | 1995-07-11 | 99 | 0 |
| K945951 | QUIKPAC II, ONE STEP HCG COMBO KIT | Syntron Bioresearch, Inc. | 1995-02-08 | 64 | 0 |
| K930488 | BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST | Syntron Bioresearch, Inc. | 1993-04-06 | 67 | 0 |
| K924007 | QUIKPAC STREP A TEST | Syntron Bioresearch, Inc. | 1993-04-06 | 239 | 0 |
| K921099 | SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST | Syntron Bioresearch, Inc. | 1992-05-29 | 81 | 0 |
| K912316 | QUIKPAC-II ONE STEP PREGNANCY HOME TEST | Syntron Bioresearch, Inc. | 1991-07-24 | 61 | 0 |
| K874248 | SYNTRON BIORESEARCH U-TEST PREGNANCY TEST | Syntron Bioresearch, Inc. | 1987-11-04 | 19 | 0 |
| K871602 | MICROCHECK LH OVULATION TEST | Syntron Bioresearch, Inc. | 1987-06-11 | 48 | 0 |
| K870751 | SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST | Syntron Bioresearch, Inc. | 1987-05-20 | 84 | 0 |
| K865076 | SYNTRON BIORESEARCH MICROCHECK HCG PREGNANCY TEST | Syntron Bioresearch, Inc. | 1987-02-11 | 44 | 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