Litton Bionetics
Medical device manufacturer in Charleston, SC.
15510(k) clearances
0PMA approvals
0recalls
Device types
- GLZ Antigens, If, Toxoplasma Gondii 3
- JRY Antiserum, Fluorescent, Epstein-Barr Virus 2
- GOL Antigen, Ha (Including Ha Control), Rubella 2
- GQH Antigen, Cf (Including Cf Control)… 2
- GQN Antigen, Cf (Including Cf Control)… 2
- LFX Enzyme Linked Immunoabsorbent Assay, Rubella 1
- LFZ Enzyme Linked Immunoabsorbent Assay… 1
- LIQ Enzyme Linked Immunoabsorbent Assay… 1
- LLM Test, Antigen, Nuclear, Epstein-Barr Virus 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K840417 | Ebna Acif KitLLM · Traditional | 12/27/1984SE |
| K834443 | Rotavirus Bio-Enzabead Screen KitLIQ · Traditional | 03/16/1984SE |
| K831343 | CMV RQ Bio-Enzabead KitLFZ · Traditional | 08/08/1983SE |
| K822985 | Ebv-M KitJRY · Traditional | 12/03/1982SE |
| K821804 | Rubella RQ Bio-Enzabead KitLFX · Traditional | 09/14/1982SE |
| K801722 | CMV Bio-Bead Titration KitGQH · Traditional | 09/16/1980SE |
| K801721 | HSV Bio-Bead Titration KitGQN · Traditional | 09/16/1980SE |
| K801720 | Toxo Bio-Bead Titration KitGLZ · Traditional | 09/16/1980SE |
| K800789 | Rubella Bio-Bead Titration KitGOL · Traditional | 06/30/1980SE |
| K791618 | Torch Bio-Bead Screen KitGLZ · Traditional | 11/13/1979SE |
| K791614 | HSV Bio-Bead Screen KitGQN · Traditional | 11/13/1979SE |
| K791612 | CMV Bio-Bead Screen KitGQH · Traditional | 11/13/1979SE |
| K791611 | Toxo Bio-Bead Screen KitGLZ · Traditional | 11/13/1979SE |
| K791610 | Rubella Bio-Bead Screen KitGOL · Traditional | 11/13/1979SE |
| K780925 | Eb-Vca, Test, Antibody, FluorescentJRY · Traditional | 06/22/1978SE |