Stellar Bio Systems, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Stellar Bio Systems, Inc.” (first 1988, latest 1999), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 106 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 |
|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 1 | 1 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 1 | 1 |
| JRY | Antiserum, Fluorescent, Epstein-Barr Virus | 1 | 1 |
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase | 1 | 1 |
| LKI | Antisera, Fluorescent, Chlamydia Spp. | 1 | 1 |
| LSE | Epstein-Barr Virus, Other | 1 | 1 |
Review panels
- Microbiology (5)
- Immunology (2)
Most recent Stellar Bio Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992587 | EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM | LSE | 1999-12-22 | 142 |
| K990916 | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY | KTL | 1999-04-21 | 34 |
| K990915 | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY | DHN | 1999-04-21 | 34 |
| K914953 | IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY | LKI | 1992-02-19 | 106 |
| K905608 | INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 | GQL | 1991-11-07 | 328 |
| K900974 | INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. | JRY | 1990-04-16 | 45 |
| K882835 | INDIRECT FLUORESCENT ASSAY FOR (HCMV) | GQH | 1988-12-05 | 150 |
Recalls
openFDA lists no recalls under a recalling firm named Stellar Bio Systems, 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.
- Stellar Medical, LLC (2 510(k)s)
- Stellar Contact Lens, Inc. (1 510(k)s)
- Stellar Labs, Inc. (1 510(k)s)
- Stellar Lasers (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Stellar Bio Systems, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Stellar Bio Systems, Inc.” (first 1988, latest 1999), across 7 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 Stellar Bio Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stellar Bio Systems, Inc. is 106 days.
Which FDA product codes appear under Stellar Bio Systems, Inc.?
The most frequent FDA product codes under this applicant name are DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, 1); GQH (Antigen, Cf (Including Cf Control), Cytomegalovirus, 1); GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2, 1).
Next steps
- See all 7 Stellar Bio Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DHN, Stellar Bio Systems, 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.