Data / Medical devices / United States / Bio-Analysis, Inc.
Bio-Analysis, Inc.: FDA-registered device maker in Santa Monica, CA, United States, 2 510(k) clearances
Bio-Analysis, Inc. is registered with the FDA (registration 2018685) in Santa Monica, CA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 19, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2018685
- Address
- 1701 Berkeley ST., Santa Monica, CA, United States, 90404
- Owner or operator
- BIO-ANALYSIS, INC. (2018685)
- Roles
- Manufacturer
- First device listed
- June 25, 2012
- Registered through
- 2026
- Brand names listed
- Pantex AM/PM Salivary Cortisol Enzyme Immunoassay, Pantex Salivary Direct Testosterone Enzyme Immunoassay (EIA) Kit, Pantex Sample Collection Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Enzyme Immunoassay, Cortisol, Salivary | NHG | 2 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | 1 | Manufacturer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 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 |
|---|---|---|---|---|---|---|
| November 19, 2014 | K133303 | PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device | JKA | Substantially Equivalent | Bio-Analysis, Inc. | accessdata.fda.gov |
| May 8, 2012 | K102841 | PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY | NHG | Substantially Equivalent | Pantex, Div. Bio-Analysis, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Enzyme Immunoassay, Cortisol, Salivary
- All makers of Radioimmunoassay, Testosterones And Dihydrotestosterone
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
Updated November 19, 2014. 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.