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FDA 510(k)

RIA KIT, QUANTITOPE T3 UPTAKE

K-Number: K781905 · 1979-01-03

ApplicantKallestad Laboratories, Inc.
Decision Date1979-01-03
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIA KIT, QUANTITOPE T3 UPTAKE is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1979-01-03 under 510(k) number K781905. 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 RIA KIT, QUANTITOPE T3 UPTAKE?

RIA KIT, QUANTITOPE T3 UPTAKE is a medical device that received FDA 510(k) clearance on 1979-01-03. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K781905.

When did RIA KIT, QUANTITOPE T3 UPTAKE receive FDA 510(k) clearance?

RIA KIT, QUANTITOPE T3 UPTAKE received FDA 510(k) clearance on 1979-01-03, under 510(k) number K781905.

Who is the listed applicant for RIA KIT, QUANTITOPE T3 UPTAKE?

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

What is the FDA product code for RIA KIT, QUANTITOPE T3 UPTAKE?

The FDA product code for RIA KIT, QUANTITOPE T3 UPTAKE is KHQ.

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Other records listing Kallestad Laboratories, 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.

K863681PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEMK862917PATHFINDER ROTAVIRUS CHEMILUMINESCENTK863682PATHFINDER(TM) SPECIMEN COLLECTION KITK862743PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUSK862313KALLESTAD SM/RNP TEST REAGENTK862710KALLESTAD SSA/SSB ENA TEST REAGENTS

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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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