Antibodies, Inc.
Medical device manufacturer in Davis, CA.
16510(k) clearances
0PMA approvals
0recalls
Device types
- CFN Method, Nephelometric, Immunoglobulins (G… 3
- DNJ Radioimmunoassay, Digoxin (125-I), Goat… 1
- CDP Radioimmunoassay, Total Triiodothyronine 1
- DJB Radioimmunoassay, Gentamicin (125-I)… 1
- CZW Complement C3, Antigen, Antiserum, Control 1
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 1
- KLB Radioimmunoassay, Tobramycin 1
- KLQ Radioimmunoassay, Amikacin 1
- DHN Antinuclear Antibody, Indirect… 1
- LCS Radioimmunoassay, Digoxin (125-I) 1
- CGR Radioimmunoassay, Cortisol 1
- GTZ Antisera, All Groups, Streptococcus Spp. 1
- KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K890774 | Giardeia(Tm)KHW · Traditional | 04/04/1989SE |
| K843590 | Detect-A-StrepGTZ · Traditional | 10/30/1984SE |
| K822892 | Cortisol Ria KitCGR · Traditional | 11/01/1982SE |
| K812749 | Ultra-DigLCS · Traditional | 10/19/1981SE |
| K812314 | Crithidna Anti-Dna Test KitDHN · Traditional | 09/01/1981SE |
| K802877 | Amikacin Ria KitKLQ · Traditional | 12/19/1980SE |
| K800743 | Tobramycin Ria KitKLB · Traditional | 04/16/1980SE |
| K791217 | TSH Ria KitJLW · Traditional | 09/04/1979SE |
| K781656 | Nephelrate Antiserums, IggCFN · Traditional | 11/08/1978SE |
| K781655 | Nephelrate Antiserums 1GACFN · Traditional | 11/08/1978SE |
| K781654 | Nephelrate Antiperums LGMCFN · Traditional | 11/08/1978SE |
| K781653 | Nephelrate Antiserums C3CCZW · Traditional | 11/08/1978SE |
| K780516 | Gentamicin Ria KitDJB · Traditional | 04/28/1978SE |
| K772122 | T3 Ria KitCDP · Traditional | 11/17/1977SE |
| K771877 | Digoxin Ria KitDNJ · Traditional | 10/21/1977SE |
| K771585 | T3 Uptake Diag. Kit · Traditional | 09/13/1977SE |