Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PTH RIA 200

K-Number: K791128 · 1979-09-27

ApplicantInstitut National Des Radioelements
Decision Date1979-09-27
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PTH RIA 200 is the device name listed in this FDA 510(k) record. The listed applicant is Institut National Des Radioelements. It received FDA 510(k) clearance on 1979-09-27 under 510(k) number K791128. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTH RIA 200?

PTH RIA 200 is a medical device that received FDA 510(k) clearance on 1979-09-27. The listed applicant is Institut National Des Radioelements. The 510(k) number is K791128.

When did PTH RIA 200 receive FDA 510(k) clearance?

PTH RIA 200 received FDA 510(k) clearance on 1979-09-27, under 510(k) number K791128.

Who is the listed applicant for PTH RIA 200?

The FDA 510(k) record lists Institut National Des Radioelements as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PTH RIA 200?

The FDA product code for PTH RIA 200 is CEW.

Other records listing Institut National Des Radioelements as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K842267C-PEP-RIA-100

Related Devices (Code: CEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231927Elecsys PTH , Elecsys PTH STATRoche DiagnosticsK232791Access Intact PTHBeckman Coulter, Inc.K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical DiagnosticsK190702Lumipulse G whole PTHFujirebio Diagnostics,Inc.K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.K161158IDS-iSYS Intact PTHNImmunodiagnostic Systems , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑