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)

THYRO-INDICATOR T-3 125I

K-Number: K780018 · 1978-02-07

ApplicantClinical Immuno-Diagnostics
Decision Date1978-02-07
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THYRO-INDICATOR T-3 125I is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Immuno-Diagnostics. It received FDA 510(k) clearance on 1978-02-07 under 510(k) number K780018. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THYRO-INDICATOR T-3 125I?

THYRO-INDICATOR T-3 125I is a medical device that received FDA 510(k) clearance on 1978-02-07. The listed applicant is Clinical Immuno-Diagnostics. The 510(k) number is K780018.

When did THYRO-INDICATOR T-3 125I receive FDA 510(k) clearance?

THYRO-INDICATOR T-3 125I received FDA 510(k) clearance on 1978-02-07, under 510(k) number K780018.

Who is the listed applicant for THYRO-INDICATOR T-3 125I?

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

What is the FDA product code for THYRO-INDICATOR T-3 125I?

The FDA product code for THYRO-INDICATOR T-3 125I is CDP.

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 Clinical Immuno-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.

K771415RIA FOR SERUM THYROXINE

Related Devices (Code: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

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.

↑