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)

RIA SYSTEM, PARATHYROID HORMONE

K-Number: K782081 · 1979-03-21

ApplicantIso-Tex Diagnostics
Decision Date1979-03-21
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIA SYSTEM, PARATHYROID HORMONE is the device name listed in this FDA 510(k) record. The listed applicant is Iso-Tex Diagnostics. It received FDA 510(k) clearance on 1979-03-21 under 510(k) number K782081. 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 RIA SYSTEM, PARATHYROID HORMONE?

RIA SYSTEM, PARATHYROID HORMONE is a medical device that received FDA 510(k) clearance on 1979-03-21. The listed applicant is Iso-Tex Diagnostics. The 510(k) number is K782081.

When did RIA SYSTEM, PARATHYROID HORMONE receive FDA 510(k) clearance?

RIA SYSTEM, PARATHYROID HORMONE received FDA 510(k) clearance on 1979-03-21, under 510(k) number K782081.

Who is the listed applicant for RIA SYSTEM, PARATHYROID HORMONE?

The FDA 510(k) record lists Iso-Tex Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIA SYSTEM, PARATHYROID HORMONE?

The FDA product code for RIA SYSTEM, PARATHYROID HORMONE is CEW.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Iso-Tex Diagnostics 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.

K851389APO B RIA KITK840105APO A-I RIA KIT-HUMAN PLASMA APOLIP-

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.

↑