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FDA 510(k)

TIPSEP-T3U TRIIODOTHYRONINE UPTAKE

K-Number: K792484 · 1979-12-27

ApplicantNuclear Diagnostics, Inc.
Decision Date1979-12-27
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TIPSEP-T3U TRIIODOTHYRONINE UPTAKE is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Diagnostics, Inc.. It received FDA 510(k) clearance on 1979-12-27 under 510(k) number K792484. 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 TIPSEP-T3U TRIIODOTHYRONINE UPTAKE?

TIPSEP-T3U TRIIODOTHYRONINE UPTAKE is a medical device that received FDA 510(k) clearance on 1979-12-27. The listed applicant is Nuclear Diagnostics, Inc.. The 510(k) number is K792484.

When did TIPSEP-T3U TRIIODOTHYRONINE UPTAKE receive FDA 510(k) clearance?

TIPSEP-T3U TRIIODOTHYRONINE UPTAKE received FDA 510(k) clearance on 1979-12-27, under 510(k) number K792484.

Who is the listed applicant for TIPSEP-T3U TRIIODOTHYRONINE UPTAKE?

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

What is the FDA product code for TIPSEP-T3U TRIIODOTHYRONINE UPTAKE?

The FDA product code for TIPSEP-T3U TRIIODOTHYRONINE UPTAKE is KHQ.

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Other records listing Nuclear Diagnostics, Inc. 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.

K923917ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAYK932406NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KITK872177TIPSEP-CORTISOL RIA DIAGNOSTIC KITK862312ENZLIPASE, ENZYMATIC LIPASE KITK860472NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESSK861735TIPSEP-TBG ASSAY

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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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