Advanced Biological Products, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Advanced Biological Products, Inc.” (first 1993, latest 1993), across 1 product code in 1 review panel. Median 510(k) review time under this name: 231 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 |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 8 | 8 |
Review panels
- Immunology (8)
Most recent Advanced Biological Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K924952 | ELISA-DOXA COMBI-6 | LLL | 1993-05-19 | 231 |
| K924951 | ELISA-DOXA COMBI-4 | LLL | 1993-05-19 | 231 |
| K924950 | ELISA-DOXA JO-1 | LLL | 1993-05-19 | 231 |
| K924949 | ELISA-DOXA SCL-70 | LLL | 1993-05-19 | 231 |
| K924948 | ELISA-DOXA SM/RNP | LLL | 1993-05-19 | 231 |
| K924947 | ELISA-DOXA SM | LLL | 1993-05-19 | 231 |
| K924946 | ELISA-DOXA SSB | LLL | 1993-05-19 | 231 |
| K924945 | ELISA-DPXA SSA KIT | LLL | 1993-05-19 | 231 |
Recalls
openFDA lists no recalls under a recalling firm named Advanced Biological Products, 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.
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.
- Advanced Cardiovascular Systems, Inc. (103 510(k)s)
- Advanced Surgical Products, Inc. (64 510(k)s)
- Advanced Technology Laboratories, Inc. (61 510(k)s)
- Advanced Sterilization Products (59 510(k)s)
- Advanced Neuromodulation Systems (25 510(k)s)
- Advanced Orthopaedic Solutions, Inc. (24 510(k)s)
- Advanced Biosearch Assn. (22 510(k)s)
- Advanced Biomedical Methods, Inc. (21 510(k)s)
- Advanced Surgical, Inc. (21 510(k)s)
- Advanced Clinical Diagnostics (19 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
- Advanced Instruments, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Biological Products, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Advanced Biological Products, Inc.” (first 1993, latest 1993), across 1 product code 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 Advanced Biological Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Biological Products, Inc. is 231 days.
Which FDA product codes appear under Advanced Biological Products, Inc.?
The most frequent FDA product codes under this applicant name are LLL (Extractable Antinuclear Antibody, Antigen And Control, 8).
Next steps
- See all 8 Advanced Biological Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLL, Advanced Biological Products, 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.