Bio/Data Corp.: FDA filings under this applicant name
FDA lists 37 510(k) clearances under the applicant name “Bio/Data Corp.” (first 1977, latest 2000), across 15 product codes in 3 review panels. Median 510(k) review time under this name: 40 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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 13 | 13 |
| GGW | Test, Time, Partial Thromboplastin | 3 | 3 |
| GJA | Test, Thrombin Time | 3 | 3 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 2 | 2 |
| GKP | Instrument, Coagulation, Automated | 2 | 2 |
| JBX | Aggregrometer, Platelet | 2 | 2 |
| JCE | Solution, Isotonic | 2 | 2 |
| JOZ | System, Automated Platelet Aggregation | 2 | 2 |
| KQJ | System, Fibrinogen Determination | 2 | 2 |
| GGC | Control, Plasma, Abnormal | 1 | 1 |
Plus 5 more product codes.
Review panels
- Hematology (34)
- Pathology (2)
- Clinical Chemistry (1)
Most recent Bio/Data Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001891 | MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C | GKP | 2000-07-12 | 21 |
| K943153 | MICROSAMPLE COAGULATION ANALYZER | GKP | 1995-03-24 | 267 |
| K893650 | PLATELET AGGREGATION PROFILER MODEL PAP-4C | JPA | 1989-06-23 | 39 |
| K881150 | KINETIC FIBRINOGEN ASSAY | GIS | 1988-03-28 | 11 |
| K873382 | PLATELET EXTRACT REAGENT | GGW | 1987-11-20 | 88 |
| K860751 | VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA | JPK | 1986-03-18 | 18 |
| K860342 | MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP | JPA | 1986-03-04 | 34 |
| K854546 | MICROSAMPLE COAGULATION ANALYSER MODEL 110P | JPA | 1986-01-07 | 55 |
| K853897 | CITREX H | GGW | 1985-10-10 | 20 |
| K853246 | CALCIUM CHLORIDE | JPA | 1985-08-13 | 12 |
27 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bio/Data Corp..
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 Bio/Data Corp.?
FDA lists 37 510(k) clearances under the applicant name “Bio/Data Corp.” (first 1977, latest 2000), across 15 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 Bio/Data Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bio/Data Corp. is 40 days.
Which FDA product codes appear under Bio/Data Corp.?
The most frequent FDA product codes under this applicant name are JPA (System, Multipurpose For In Vitro Coagulation Studies, 13); GGW (Test, Time, Partial Thromboplastin, 3); GJA (Test, Thrombin Time, 3).
Next steps
- See all 37 Bio/Data Corp. clearances with predicates and recalls
- Run predicate analysis for product code JPA, Bio/Data Corp.'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.