C. PTH Radioimmunoassay Kit-CPTHK

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K833768 ↗

FDA Product Code

CEW

Device Class

Class II

Regulation

21 CFR Part 862.1545

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• S80 Implantable Cardiac Pacing Lead

  Class III

  FDA 510(k) K854963 Active Cleared 24 Jun 1986

• Bcd Advanced Blood Carioplegia Systems

  Class II

  FDA 510(k) K925369 Active Cleared 26 Mar 1993

• Diria-Progk Immunoassay

  Class I

  FDA 510(k) K832694 Active Cleared 11 Jan 1984

• Stockert 1/4 Bubble Sensor

  Class II

  FDA 510(k) K925541 Active Cleared 2 Feb 1993

• Digoctk 125

  Class II

  FDA 510(k) K800773 Active Cleared 24 Apr 1980

• Renctk

  Class II

  FDA 510(k) K800774 Active Cleared 21 Apr 1980

See all devices from Sorin Biomedica, Fiat, USA, Inc. →

• What is the C. PTH Radioimmunoassay Kit-CPTHK used for?

  This device is a radioimmunoassay kit designed for in vitro diagnostic use to quantify parathyroid hormone (PTH) levels in patient specimens within clinical chemistry settings, enabling laboratories to measure PTH for diagnostic evaluation.

• How is the C. PTH Radioimmunoassay Kit-CPTHK supplied and what is its regulatory classification?

  The kit is supplied as a traditional 510(k) cleared in vitro diagnostic reagent system, classified under regulation number 862.1545 and product code CEW, indicating it is a Class II device cleared for clinical laboratory use based on substantial equivalence to a predicate device.

• Is the C. PTH Radioimmunoassay Kit-CPTHK described as sterile, single-use, or reusable in the provided data?

  The device data does not describe the kit as sterile, single-use, reusable, or MRI safe; therefore, no claims about sterility or reusability can be made based on the information provided, and users should consult the manufacturer's labeling for specific handling instructions.