Syntron Bioresearch, Inc.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Syntron Bioresearch, Inc.” (first 1987, latest 1999), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 62 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 | 0 | — |
| 2013 | 0 | — |
| 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 |
|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 6 | 6 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 3 | 3 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 3 | 3 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 3 | 3 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 3 | 3 |
| DIS | Enzyme Immunoassay, Barbiturate | 2 | 2 |
| DJG | Enzyme Immunoassay, Opiates | 2 | 2 |
| LCM | Enzyme Immunoassay, Phencyclidine | 2 | 2 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 | 1 |
Review panels
- Clinical Chemistry (12)
- Clinical Toxicology (11)
- Microbiology (3)
Most recent Syntron Bioresearch, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993491 | QUICKPAC II ONE STEP OPIATES TEST | DJG | 1999-10-29 | 14 |
| K993490 | QUICKSTRIP ONE STEP OPIATES TEST | DJG | 1999-10-29 | 14 |
| K992990 | QUICKPAC II ONE STEP COCAINE TEST | DIO | 1999-09-20 | 13 |
| K992748 | DRUGCHECK X MULTIDRUG SCREENING DEVICE | DIO | 1999-09-02 | 17 |
| K992207 | QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM | DIO | 1999-07-22 | 22 |
| K990325 | QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE | DKZ | 1999-06-24 | 142 |
| K983113 | BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT | CEP | 1998-11-18 | 75 |
| K981292 | QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST | LCM | 1998-05-26 | 47 |
| K981019 | QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST | LCM | 1998-05-07 | 50 |
| K980349 | QUICKPAC II ONE STEP BARBITURATE TEST | DIS | 1998-03-03 | 34 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Syntron Bioresearch, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Syntron Bioresearch, Inc.?
FDA lists 26 510(k) clearances under the applicant name “Syntron Bioresearch, Inc.” (first 1987, latest 1999), across 10 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 Syntron Bioresearch, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Syntron Bioresearch, Inc. is 62 days.
Which FDA product codes appear under Syntron Bioresearch, Inc.?
The most frequent FDA product codes under this applicant name are LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 6); CEP (Radioimmunoassay, Luteinizing Hormone, 3); DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 3).
Next steps
- See all 26 Syntron Bioresearch, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LCX, Syntron Bioresearch, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.