PTH Ria 200

FDA 510(k) K791128 · Institut National Des Radioelements

Substantially Equivalent

510(k) numberK791128

Submission

Device name
PTH Ria 200
Applicant
Institut National Des Radioelements
Mchenry, IL, US
Received
June 18, 1979
Decision date
September 27, 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

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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

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Questions and answers

When was PTH Ria 200 cleared by the FDA?

PTH Ria 200 (K791128) received a 510(k) decision of Substantially Equivalent on September 27, 1979, 101 days after the submission was received.

What is the product code of K791128?

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