Ria System, Parathyroid Hormone

FDA 510(k) K782081 · Iso-Tex Diagnostics

Substantially Equivalent

510(k) numberK782081

Submission

Device name
Ria System, Parathyroid Hormone
Applicant
Iso-Tex Diagnostics
Walker, MI, US
Received
December 13, 1978
Decision date
March 21, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CEW – Radioimmunoassay, Parathyroid Hormone
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1545
Specialty
Clinical Chemistry

Other 510(k)s with product code CEW

510(k)DeviceApplicantDecision
K231927Elecsys PTH , Elecsys PTH STATCEW · Traditional Roche Diagnostics03/22/2024SE
K232791Access Intact PTHCEW · Traditional Beckman Coulter, Inc.03/01/2024SE
K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackCEW · Traditional Ortho Clinical Diagnostics09/05/2023SE
K190702Lumipulse G whole PTHCEW · Traditional Fujirebio Diagnostics,Inc.08/30/2019SE
K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssayCEW · Traditional Siemens Healthcare Diagnostics, Inc.05/23/2017SE
K161158IDS-iSYS Intact PTHNCEW · Traditional Immunodiagnostic Systems , Ltd.01/31/2017SE
K150879LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration VerifiersCEW · Traditional DiaSorin, Inc.06/22/2015SE
K133601Advia Centaur Intact Parathyroid Hormone (Ipth) AssayCEW · Traditional Siemens Healthcare Diagnostics, Inc.02/05/2014SE
K132515Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersCEW · Traditional DiaSorin, Inc.11/08/2013SE
K121981Advia Centaur Inact Parathyroid Hormone (Ipth) AssayCEW · Traditional Siemens Healthcare Diagnostics03/21/2013SE

More from Siemens Healthcare Diagnostics

510(k)DeviceDecision
K851389Apo B Ria KitMSJ · Traditional 07/10/1985SE
K840105Apo A-I Ria Kit-Human Plasma Apolip- · Traditional 01/10/1984SESP

Questions and answers

When was Ria System, Parathyroid Hormone cleared by the FDA?

Ria System, Parathyroid Hormone (K782081) received a 510(k) decision of Substantially Equivalent on March 21, 1979, 98 days after the submission was received.

What is the product code of K782081?

The FDA product code is CEW – Radioimmunoassay, Parathyroid Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1545.