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)

T3 UPTAKE CHEMILUMINESCENCE ASSAY

K-Number: K926220 · 1993-11-17

ApplicantNichols Institute Diagnostics
Decision Date1993-11-17
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T3 UPTAKE CHEMILUMINESCENCE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute Diagnostics. It received FDA 510(k) clearance on 1993-11-17 under 510(k) number K926220. The device is classified under product code KHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T3 UPTAKE CHEMILUMINESCENCE ASSAY?

T3 UPTAKE CHEMILUMINESCENCE ASSAY is a medical device that received FDA 510(k) clearance on 1993-11-17. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K926220.

When did T3 UPTAKE CHEMILUMINESCENCE ASSAY receive FDA 510(k) clearance?

T3 UPTAKE CHEMILUMINESCENCE ASSAY received FDA 510(k) clearance on 1993-11-17, under 510(k) number K926220.

Who is the listed applicant for T3 UPTAKE CHEMILUMINESCENCE ASSAY?

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

What is the FDA product code for T3 UPTAKE CHEMILUMINESCENCE ASSAY?

The FDA product code for T3 UPTAKE CHEMILUMINESCENCE ASSAY is KHQ.

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 Nichols Institute 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.

K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYK042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYK042689NICHOLS ADVANTAGE CORTISOLK040813NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022K033727NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYK033302NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

View all 68 devices →

Related Devices (Code: KHQ)

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.

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobindK970539CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.K954807CEDIA T UPTAKE ASSAYBoehringer Mannheim Corp.

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.

↑