Biological Corp. of America: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Biological Corp. of America” (first 1976, latest 1982), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 46 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 |
|---|---|---|---|
| KSG | Media, Potentiating For In Vitro Diagnostic Use | 3 | 3 |
| KSK | Solution, Stabilized Enzyme | 2 | 2 |
| JPK | Mixture, Hematology Quality Control | 1 | 1 |
Review panels
- Hematology (6)
Most recent Biological Corp. of America 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K813404 | FREEZE DRIED FICIN | KSK | 1982-02-10 | 65 |
| K812565 | ELUTION SOLUTION | KSG | 1981-10-23 | 44 |
| K812222 | EM-X | KSG | 1981-09-23 | 47 |
| K810803 | FREEZE DRIED PAPAIN | KSK | 1981-07-21 | 119 |
| K781397 | EM-V | KSG | 1978-09-14 | 34 |
| K760162 | HEMATOLOGY CONTROL | JPK | 1976-08-04 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Biological Corp. of America.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Biological & Environmental Control Laboratories (20 510(k)s)
- Biological Signal Processing, Ltd. (5 510(k)s)
- Biological Controls, Inc. (2 510(k)s)
- Biological Industries (2 510(k)s)
- Biological & Diagnostic Products (1 510(k)s)
- Biological Rescue Products, Inc. (1 510(k)s)
- Biological Resistance, Inc. (1 510(k)s)
- Biological Technology Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biological Corp. of America?
FDA lists 6 510(k) clearances under the applicant name “Biological Corp. of America” (first 1976, latest 1982), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biological Corp. of America?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biological Corp. of America is 46 days.
Which FDA product codes appear under Biological Corp. of America?
The most frequent FDA product codes under this applicant name are KSG (Media, Potentiating For In Vitro Diagnostic Use, 3); KSK (Solution, Stabilized Enzyme, 2); JPK (Mixture, Hematology Quality Control, 1).
Next steps
- See all 6 Biological Corp. of America clearances with predicates and recalls
- Run predicate analysis for product code KSG, Biological Corp. of America'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.