Salimetrics LLC.
State College, PA, US
SALIMETRICS LLC. appears in FDA device records in State College, PA. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Salimetrics LLC. between 2001 and 2005. The busiest year on record is 2001, with 1. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2003 | 1 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K051012 | PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML. | JIT | Substantially Equivalent | |
| K031348 | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY | NHG | Substantially Equivalent | |
| K011323 | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 | NHG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003760091 | 3003760091 | SALIMETRICS LLC. | 101 INNOVATION BLVD STE 302, State College, PA 16803 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JITCalibrator, Secondary
- NNKContainer, Specimen Mailer And Storage, Non-Sterile
- NHGEnzyme Immunoassay, Cortisol, Salivary
- MKUEnzyme Immunoassay, Nicotine And Nicotine Metabolites
- FRLFiber, Medical, Absorbent
- CHPRadioimmunoassay, Estradiol
- CFPRadioimmunoassay, Immunoreactive Insulin
- JLSRadioimmunoassay, Progesterone
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain