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FDA 510(k)

T3 UPTAKE TEST

K-Number: K780361 · 1978-03-22

ApplicantMonobind
Decision Date1978-03-22
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T3 UPTAKE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Monobind. It received FDA 510(k) clearance on 1978-03-22 under 510(k) number K780361. 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 TEST?

T3 UPTAKE TEST is a medical device that received FDA 510(k) clearance on 1978-03-22. The listed applicant is Monobind. The 510(k) number is K780361.

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

T3 UPTAKE TEST received FDA 510(k) clearance on 1978-03-22, under 510(k) number K780361.

Who is the listed applicant for T3 UPTAKE TEST?

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

What is the FDA product code for T3 UPTAKE TEST?

The FDA product code for T3 UPTAKE TEST is KHQ.

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Other records listing Monobind 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.

K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300K020548FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300K980088T-UPTAKE MICROPLATE EIAK972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAK971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA

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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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