General Biometrics, Inc.
Medical device manufacturer in San Diego, CA.
23510(k) clearances
0PMA approvals
0recalls
Device types
- LSR Reagent, Borrelia Serological Reagent 4
- LFX Enzyme Linked Immunoabsorbent Assay, Rubella 3
- LLL Extractable Antinuclear Antibody, Antigen… 3
- LJM Antinuclear Antibody (Enzyme-Labeled)… 2
- JNL Immunochemical, Thyroglobulin Autoantibody 2
- LKP Anti-Sm Antibody, Antigen And Control 2
- LKO Anti-Rnp Antibody, Antigen And Control 2
- MID System, Test, Anticardiolipin Immunological 2
- KTN System, Test, Infectious Mononucleosis 1
- JZO System, Test, Thyroid Autoantibody 1
- DHC System, Test, Systemic Lupus Erythematosus 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K924843 | Immunodot(R) Ena/Dna Autoimmunity Screening PanelLLL · Traditional | 12/01/1992SE |
| K920401 | Immunowell Cardiolipin Antibody (Igm) TestMID · Traditional | 08/20/1992SE |
| K920400 | Immunowell Cardiolipin Antibody (Igg) TestMID · Traditional | 08/20/1992SE |
| K911627 | Immunodot Borrelia (Lyme) TestLSR · Traditional | 04/08/1992SE |
| K911599 | Immunowell Lyme (P39 Recombinant) TestLSR · Traditional | 12/30/1991SE |
| K911590 | Immunowell Borrelia (Lyme)TestLSR · Traditional | 12/20/1991SE |
| K914801 | Immunowell Dsdna Antibody TestDHC · Traditional | 12/09/1991SE |
| K911851 | Immunowell SM Antibody TestLKP · Traditional | 05/07/1991SE |
| K911850 | Immunwell Sjogren`S Syndrome B (la) Antibody TestLKO · Traditional | 05/07/1991SE |
| K911849 | Immunowell Sjogrens Syndrome a (Ro)Antibody TestLKO · Traditional | 05/07/1991SE |
| K911848 | Immunowell Rnp/Sm Antibody TestLKP · Traditional | 05/07/1991SE |
| K905485 | Immunowell Thyroglobulin TestJZO · Traditional | 01/25/1991SE |
| K905486 | Immunowell Tpo (Microsome) TestJNL · Traditional | 01/03/1991SE |
| K903843 | Immunodot Thyroid Autoimmunity PanelJNL · Traditional | 10/02/1990SE |
| K903047 | Immumodot Autoimmunity Screening Panel 4LLL · Traditional | 08/09/1990SE |
| K902938 | Immunodot Autoimmunity Screening Panel 3LLL · Traditional | 08/09/1990SE |
| K900072 | Immunodot Autoimmunity Screening Panel 2LJM · Traditional | 01/24/1990SE |
| K896347 | Immunodot Autoimmune Screening Panel 1LJM · Traditional | 12/05/1989SE |
| K894410 | Immunodot Lyme TestLSR · Traditional | 10/30/1989SE |
| K894546 | Immunodot Rubella TestLFX · Traditional | 10/16/1989SE |
| K894975 | Immunodot Infectious Mononucleosis TestKTN · Traditional | 09/13/1989SE |
| K884898 | Immunodot Torch Test RubellaLFX · Traditional | 02/03/1989SE |
| K885082 | Immunodot Rubella TestLFX · Traditional | 02/02/1989SE |