Biokit USA, Inc.
Medical device manufacturer in Barcelona, ES.
16510(k) clearances
0PMA approvals
0recalls
Device types
- GTQ Antistreptolysin - Titer/Streptolysin O… 4
- DHR System, Test, Rheumatoid Factor 3
- LQN Latex Agglutination Assay, Rubella 2
- DCN System, Test, C-Reactive Protein 2
- GMP Antisera, Control For Nontreponemal Tests 1
- KTN System, Test, Infectious Mononucleosis 1
- DCK C-Reactive Protein, Antigen, Antiserum, And… 1
- GMQ Antigens, Nontreponemal, All 1
- LLA Direct Agglutination Test, Toxoplasma Gondii 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K913467 | ToxogenLLA · Traditional | 01/11/1993SE |
| K910541 | Biokit RPRGMQ · Traditional | 10/18/1991SE |
| K904310 | Rheumagen RF T-ControlDHR · Traditional | 05/31/1991SE |
| K910539 | Rheumajet RFDHR · Traditional | 04/05/1991SE |
| K910686 | Rheumajet CRPDCN · Traditional | 03/19/1991SE |
| K904311 | Rheumagen Aso T-ControlGTQ · Traditional | 01/25/1991SE |
| K904312 | Rheumagen CRP T-ControlDCK · Traditional | 10/01/1990SE |
| K896433 | Modified RubagenLQN · Traditional | 11/29/1989SE |
| K896272 | Quantex CRP Plus (Latex, Buffer, Standard, ControlDCN · Traditional | 11/08/1989SE |
| K896271 | Quantex RF Plus (Latex, Buffer Standard, Control)DHR · Traditional | 11/08/1989SE |
| K894486 | Quantex Aso Plus (Latex,Buffer Standard,Control)GTQ · Traditional | 10/24/1989SE |
| K893755 | RubagenLQN · Traditional | 08/21/1989SE |
| K874678 | I.M.N. LatexKTN · Traditional | 12/14/1987SE |
| K854991 | Reumagen AslGTQ · Traditional | 04/18/1986SE |
| K843741 | RPR Test ReditestGMP · Traditional | 10/25/1984SE |
| K842256 | AS Latex PlusGTQ · Traditional | 06/19/1984SE |