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FDA 510(k)

T3 UPTAKE RADIOIMMUNOASSAY KIT

K-Number: K791361 · 1979-08-16

ApplicantTechnia Diagnostics , Ltd.
Decision Date1979-08-16
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T3 UPTAKE RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Technia Diagnostics , Ltd.. It received FDA 510(k) clearance on 1979-08-16 under 510(k) number K791361. 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 RADIOIMMUNOASSAY KIT?

T3 UPTAKE RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1979-08-16. The listed applicant is Technia Diagnostics , Ltd.. The 510(k) number is K791361.

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

T3 UPTAKE RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1979-08-16, under 510(k) number K791361.

Who is the listed applicant for T3 UPTAKE RADIOIMMUNOASSAY KIT?

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

What is the FDA product code for T3 UPTAKE RADIOIMMUNOASSAY KIT?

The FDA product code for T3 UPTAKE RADIOIMMUNOASSAY KIT is KHQ.

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Other records listing Technia Diagnostics , Ltd. 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.

K861978AUTOFLUOR VK801843T3(125) RADIOIMMUNOASSAY KITK801202DIGOXIN RADIOIMMUNOASSAY KITK801203CORTISOL RADIOIMMUNOASSAY KITK790919HPL RIA KITK790495THYROXINE RIA KIT

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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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