Data / Medical devices / United States / Salimetrics LLC.
Salimetrics LLC.: FDA-registered device maker in State College, PA, United States, 1 510(k) clearance
Salimetrics LLC. is registered with the FDA (registration 3003760091) in State College, PA, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 10, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003760091
- Address
- 101 Innovation BLVD Ste 302, State College, PA, United States, 16803
- Owner or operator
- SALIMETRICS LLC. (9045886)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- August 29, 2005
- Registered through
- 2026
- Brand names listed
- CRYOVIAL, Expanded Range High Sensitivity Salivary Cortisol Enzyme immunoassay Kit, Expanded Sensitivity Salivary 17beta-Estradiol Enzyme Immunoassay Kit, High Sensitivity Salivary 17beta-Estradiol Enzyme Immunoassay Kit, High Sensitivity Salivary Cotinine Quantitative Enzyme Immunoassay Kit, Salimetrics Children's Swab, Salimetrics Infant's Swab, Salimetrics Oral Swab and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Cortisol, Salivary | NHG | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Enzyme Immunoassay, Nicotine And Nicotine Metabolites | MKU | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Radioimmunoassay, Estradiol | CHP | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Immunoreactive Insulin | CFP | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Progesterone | JLS | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| June 10, 2003 | K031348 | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY | NHG | Substantially Equivalent | Salimetrics, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Radioimmunoassay, Immunoreactive Insulin
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
- All makers of Radioimmunoassay, Progesterone
- All makers of Radioimmunoassay, Estradiol
- All makers of Fiber, Medical, Absorbent
- All makers of Enzyme Immunoassay, Cortisol, Salivary
Updated June 10, 2003. 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.