Stellar Bio Systems, Inc.
Columbia, MD, US
Stellar Bio Systems, Inc. appears in FDA device records in Columbia, MD. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 7
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 7 510(k) clearances for Stellar Bio Systems, Inc. between 1988 and 1999. The busiest year on record is 1999, with 3. The most recent is 1999, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1999 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K992587 | EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM | LSE | Substantially Equivalent | |
| K990916 | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY | KTL | Substantially Equivalent | |
| K990915 | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY | DHN | Substantially Equivalent | |
| K914953 | IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY | LKI | Substantially Equivalent | |
| K905608 | INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 | GQL | Substantially Equivalent | |
| K900974 | INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. | JRY | Substantially Equivalent | |
| K882835 | INDIRECT FLUORESCENT ASSAY FOR (HCMV) | GQH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KTLAnti-Dna Indirect Immunofluorescent Solid Phase
- GQHAntigen, Cf (Including Cf Control), Cytomegalovirus
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- LKIAntisera, Fluorescent, Chlamydia Spp.
- GQLAntisera, Fluorescent, Herpesvirus Hominis 1,2
- JRYAntiserum, Fluorescent, Epstein-Barr Virus
- LSEEpstein-Barr Virus, Other
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain