510(k) Report

FDA applicant

Salimetrics, LLC

State College, PA3 decisions2001–20050 recalls

FDA records 3 decisions for Salimetrics, LLC (State College, PA) from 2001 to 2005: 3 510(k) clearances. Most are in product codes NHG (Enzyme Immunoassay, Cortisol, Salivary) and JIT (Calibrator, Secondary). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Salimetrics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Salimetrics, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Salimetrics, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NHGEnzyme Immunoassay, Cortisol, Salivary2decisions
  • JITCalibrator, Secondary1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K011323High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102Salimetrics, LLC · 20012cite it

What has FDA decided for it lately?

  • K051012Progesterone Standard Calibrator, One (1) ML of Progesterone in a Saliva-Like Matrix at a Concentration of…Salimetrics, LLC · 2005
  • K031348High Sensitivity Cortisol Enzyme ImmunoassaySalimetrics, LLC · 2003
  • K011323High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102Salimetrics, LLC · 2001

All 3 as Salimetrics, LLC →