Intl. Diagnostic Technology
Medical device manufacturer in San Jose, CA.
29510(k) clearances
0PMA approvals
0recalls
Device types
- GLZ Antigens, If, Toxoplasma Gondii 2
- KTL Anti-Dna Indirect Immunofluorescent Solid… 2
- GOL Antigen, Ha (Including Ha Control), Rubella 2
- DHN Antinuclear Antibody, Indirect… 2
- DHR System, Test, Rheumatoid Factor 1
- DAB Haptoglobin, Fitc, Antigen, Antiserum… 1
- DEI Alpha-1-Antitrypsin, Fitc, Antigen… 1
- DFI Total Spinal-Fluid, Antigen, Antiserum… 1
- DCK C-Reactive Protein, Antigen, Antiserum, And… 1
- DFT Igm, Antigen, Antiserum, Control 1
- CZN Iga, Fitc, Antigen, Antiserum, Control 1
- DGK Igg, Fitc, Antigen, Antiserum, Control 1
- DBI Complement C4, Antigen, Antiserum, Control 1
- CZW Complement C3, Antigen, Antiserum, Control 1
- KLS Enzyme Immunoassay, Theophylline 1
- LCR Fluorescent Immunoassay, Tobramycin 1
- GQL Antisera, Fluorescent, Herpesvirus Hominis… 1
- LCQ Fluorescent Immunoassay Gentamicin 1
- GQH Antigen, Cf (Including Cf Control)… 1
- DCF Albumin, Antigen, Antiserum, Control 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K850591 | Fiax Toxo-M Antibodies Test KitGLZ · Traditional | 04/30/1985SE |
| K843570 | Fiax Haptoglobin Test KitDAB · Traditional | 10/05/1984SE |
| K843621 | Fiax 420 DilutorJQW · Traditional | 09/28/1984SE |
| K843356 | Fiax 100 FluorometerJZT · Traditional | 09/17/1984SE |
| K842749 | Fiax Total Ige Test KitDGP · Traditional | 08/28/1984SE |
| K842071 | Fiax Transferrin Test KitDDI · Traditional | 07/11/1984SE |
| K841174 | Rubella Antibody FluoroimmunoassayGOL · Traditional | 06/07/1984SE |
| K840867 | ALPHA-1-ANTITRYPSIN, Fitc, AntigenDEI · Traditional | 05/11/1984SE |
| K834140 | Antinuclear Antibody Immunological SysKTL · Traditional | 01/20/1984SE |
| K833984 | Antinuclear Antibody ImmunologicalKTL · Traditional | 01/04/1984SE |
| K832821 | Fiax Igg TestDFI · Traditional | 10/14/1983SE |
| K832383 | Idt Ana Stiq AssayDHN · Traditional | 08/31/1983SE |
| K832054 | Fiax CRP Test KitDCK · Traditional | 08/26/1983SE |
| K831608 | Fiax Igm Test KitDFT · Traditional | 06/22/1983SE |
| K831607 | Fiax Iga Test KitCZN · Traditional | 06/22/1983SE |
| K831609 | Fiax Igg Test KitDGK · Traditional | 06/17/1983SE |
| K830669 | Fiax Complement C4 Test KitDBI · Traditional | 04/08/1983SE |
| K830668 | Fiax Complement C3 Test KitCZW · Traditional | 04/05/1983SE |
| K812968 | Fiax Rheumatoid Factor Test KitDHR · Traditional | 11/06/1981SE |
| K801642 | Fiax Test Kit for Theophylline Quant.KLS · Traditional | 08/27/1980SE |
| K801308 | Fiax Test Kit for Tobramycin QuantitaLCR · Traditional | 06/20/1980SE |
| K792559 | Fiax Test Kit for Herpes Simplex VirusGQL · Traditional | 03/03/1980SE |
| K800032 | Fiax Test Kit for Gentamicin Quan.LCQ · Traditional | 01/23/1980SE |
| K792249 | Fiax Test Kit for Anti-Rubella AntibodGOL · Traditional | 01/23/1980SE |
| K791948 | Fiax Test Kit for Anti-CytomegalorirusGQH · Traditional | 11/16/1979SE |
| K790464 | Fiax Test Kit for Anti-Toxoplasma AntiboGLZ · Traditional | 06/13/1979SE |
| K761225 | Low Level Human Albumin Test KitsDCF · Traditional | 04/07/1977SE |
| K761224 | Ultra Low Level Immunoglobulin GDEW · Traditional | 04/07/1977SE |
| K760206 | Test, Detection, Antinuclear AntibodiesDHN · Traditional | 08/03/1976SE |