Central Biological Co.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Central Biological Co.” (first 1979, latest 1981), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 21 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 |
|---|---|---|---|
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 1 | 1 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 1 | 1 |
| JSK | Supplement, Culture Media | 1 | 1 |
Review panels
Most recent Central Biological Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K812330 | DIALYSATE CONCENTRATE | FKQ | 1981-09-29 | 42 |
| K792238 | CRPTELL | DCK | 1979-11-30 | 23 |
| K792027 | PREGTELL I | JHJ | 1979-10-30 | 21 |
| K790801 | STERILE DEFIBRINATED SHEEP BLOOD | JSK | 1979-05-03 | 14 |
| K790351 | RHEUMATELL | DHR | 1979-03-15 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Central Biological Co..
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.
- Central Medicare Sdn Bhd (15 510(k)s)
- Central Media (14 510(k)s)
- Central Solutions, Inc. (7 510(k)s)
- Central Georgia Ancillary Health Systems (3 510(k)s)
- Central Labs. Assoc. MD Pathologists (3 510(k)s)
- Central Plastic, Inc. (2 510(k)s)
- Central Chemical Co., Ltd. (1 510(k)s)
- Central Equipment Sales, Inc. (1 510(k)s)
- Central Illinois Hearing Aid Centers, Inc. (1 510(k)s)
- Central Pharmaceuticals, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Central Biological Co.?
FDA lists 5 510(k) clearances under the applicant name “Central Biological Co.” (first 1979, latest 1981), across 5 product codes in 4 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 Central Biological Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Central Biological Co. is 21 days.
Which FDA product codes appear under Central Biological Co.?
The most frequent FDA product codes under this applicant name are DCK (C-Reactive Protein, Antigen, Antiserum, And Control, 1); DHR (System, Test, Rheumatoid Factor, 1); FKQ (System, Dialysate Delivery, Central Multiple Patient, 1).
Next steps
- See all 5 Central Biological Co. clearances with predicates and recalls
- Run predicate analysis for product code DCK, Central Biological Co.'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.