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FDA 510(k)

CBR-T3 UPTAKE KIT

K-Number: K780500 · 1978-05-03

ApplicantClinical Bioresearch
Decision Date1978-05-03
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CBR-T3 UPTAKE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Bioresearch. It received FDA 510(k) clearance on 1978-05-03 under 510(k) number K780500. 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 CBR-T3 UPTAKE KIT?

CBR-T3 UPTAKE KIT is a medical device that received FDA 510(k) clearance on 1978-05-03. The listed applicant is Clinical Bioresearch. The 510(k) number is K780500.

When did CBR-T3 UPTAKE KIT receive FDA 510(k) clearance?

CBR-T3 UPTAKE KIT received FDA 510(k) clearance on 1978-05-03, under 510(k) number K780500.

Who is the listed applicant for CBR-T3 UPTAKE KIT?

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

What is the FDA product code for CBR-T3 UPTAKE KIT?

The FDA product code for CBR-T3 UPTAKE KIT 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 Clinical Bioresearch 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.

K780707T4-RIA KITK780499CBR-T3RIA KITK780498CBR-DIGOXIN ANTISERUM

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.

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