Company ยท US
Stellar Bio Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 1999. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 1 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 1 |
| JRY | Antiserum, Fluorescent, Epstein-Barr Virus | 1 |
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase | 1 |
| LKI | Antisera, Fluorescent, Chlamydia Spp. | 1 |
| LSE | Epstein-Barr Virus, Other | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 22, 1999 | K992587 | EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM Stellar Bio Systems, Inc. | LSE |
| Apr 21, 1999 | K990916 | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY Stellar Bio Systems, Inc. | KTL |
| Apr 21, 1999 | K990915 | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY Stellar Bio Systems, Inc. | DHN |
| Feb 19, 1992 | K914953 | IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY Stellar Bio Systems, Inc. | LKI |
| Nov 7, 1991 | K905608 | INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 Stellar Bio Systems, Inc. | GQL |
| Apr 16, 1990 | K900974 | INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. Stellar Bio Systems, Inc. | JRY |
| Dec 5, 1988 | K882835 | INDIRECT FLUORESCENT ASSAY FOR (HCMV) Stellar Bio Systems, Inc. | GQH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||