Data / Medical devices / United States / Antibodies Incorporated
Antibodies Incorporated: FDA-registered device maker in Davis, CA, United States, 1 510(k) clearance
Antibodies Incorporated is registered with the FDA (registration 3032523590) in Davis, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 1, 1981. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3032523590
- Address
- 1460 Drew Ave Ste 300, Davis, CA, United States, 95618
- Owner or operator
- Antibodies Incorporated (2914537)
- Roles
- Manufacturer
- First device listed
- December 4, 2007
- Registered through
- 2027
- Brand names listed
- AntiNuclear Antibody Test (ANA), CrithiDNA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | DHN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 1, 1981 | K812314 | CRITHIDNA ANTI-DNA TEST KIT | DHN | Substantially Equivalent | Antibodies, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 1, 1981. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.