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FDA 510(k)

RIA FOR SERUM THYROXINE

K-Number: K771415 · 1978-01-05

ApplicantClinical Immuno-Diagnostics
Decision Date1978-01-05
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIA FOR SERUM THYROXINE 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 1978-01-05 under 510(k) number K771415. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIA FOR SERUM THYROXINE?

RIA FOR SERUM THYROXINE is a medical device that received FDA 510(k) clearance on 1978-01-05. The listed applicant is Clinical Immuno-Diagnostics. The 510(k) number is K771415.

When did RIA FOR SERUM THYROXINE receive FDA 510(k) clearance?

RIA FOR SERUM THYROXINE received FDA 510(k) clearance on 1978-01-05, under 510(k) number K771415.

Who is the listed applicant for RIA FOR SERUM THYROXINE?

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 RIA FOR SERUM THYROXINE?

The FDA product code for RIA FOR SERUM THYROXINE is CDX.

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.

K780018THYRO-INDICATOR T-3 125I

Related Devices (Code: CDX)

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.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, Inc.

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.

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