Data / Medical devices / United States / Saladax Biomedical, Inc.
Saladax Biomedical, Inc.: FDA-registered device maker in Bethlehem, PA, United States, 1 510(k) clearance
Saladax Biomedical, Inc. is registered with the FDA (registration 3005567065) in Bethlehem, PA, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 16, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005567065
- Address
- 116 Research DR., Bethlehem, PA, United States, 18015
- Owner or operator
- SALADAX BIOMEDICAL, INC. (9097239)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- August 19, 2011
- Registered through
- 2026
- Brand names listed
- My5-FU Assay, My5-FU Calibrator Kit, My5-FU Control Kit, My5-FU Sample Stabilizer, MyCare Psychiatry Calibrator Kit 1, MyCare Psychiatry Calibrator Kit 2, MyCare Psychiatry Clozapine Assay Kit, MyCare Psychiatry Control Kit 1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 5-Fluorouracil Assay | OXR | N | Manufacturer for export | accessdata.fda.gov |
| Calibrators, Drug Specific | DLJ | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Clozapine Test System | QKT | 2 | Manufacturer | accessdata.fda.gov |
| Docetaxel / Paclitaxel Assay | PRF | N | Manufacturer for export | accessdata.fda.gov |
| Drug Specific Control Materials | LAS | 1 | Manufacturer, Manufacturer for export | 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 |
|---|---|---|---|---|---|---|
| April 16, 2020 | DEN190028 | MyCare Psychiatry Clozapine Assay Kit | QKT | Unknown | Saladax Biomedical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 16, 2020. 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.