Biovation, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Biovation, Inc.” (first 1978, latest 1993), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 52 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 |
|---|---|---|---|
| JQP | Calculator/Data Processing Module, For Clinical Use | 4 | 4 |
| GKZ | Counter, Differential Cell | 2 | 2 |
| JQX | Nephelometer, For Clinical Use | 2 | 2 |
| JGP | Lowry (Colorimetric), Total Protein | 1 | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | 1 |
| JRE | Refractometer For Clinical Use | 1 | 1 |
Review panels
- Clinical Chemistry (9)
- Hematology (2)
Most recent Biovation, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925528 | BIOVATION K-MANAGER | GKZ | 1993-02-05 | 95 |
| K923844 | LYRIS 100/120 LABORATORY INFORMATION SYSTEM | JJQ | 1992-12-11 | 133 |
| K915071 | DIFFERENTIAL COUNTING BOARD | GKZ | 1992-01-17 | 70 |
| K853026 | BIOVATION MAX DATA MANAGEMENT SYSTEM | JQP | 1985-08-02 | 15 |
| K842401 | CHEMISTRY CONSOLE | JQP | 1984-09-04 | 77 |
| K831830 | LYRIS MODULAR INFO SYSTEM | JQP | 1984-06-25 | 384 |
| K821534 | HEMATOLOGY DATA MANAGEMENT SYS | JGP | 1982-06-10 | 17 |
| K812604 | BIOVATION URINALYSIS REPORTER | JQP | 1981-10-02 | 17 |
| K792045 | BIOVATION NEPHELOMETER | JQX | 1979-10-30 | 18 |
| K790862 | BIOVATION DIGITAL URINOMETER | JRE | 1979-06-28 | 52 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biovation, 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 Biovation, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Biovation, Inc.” (first 1978, latest 1993), across 6 product codes in 2 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 Biovation, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biovation, Inc. is 52 days.
Which FDA product codes appear under Biovation, Inc.?
The most frequent FDA product codes under this applicant name are JQP (Calculator/Data Processing Module, For Clinical Use, 4); GKZ (Counter, Differential Cell, 2); JQX (Nephelometer, For Clinical Use, 2).
Next steps
- See all 11 Biovation, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JQP, Biovation, 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.