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FDA 510(k)

T3 UPTAKE KIT

K-Number: K810857 · 1981-04-08

ApplicantImmuno Assay Corp.
Decision Date1981-04-08
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T3 UPTAKE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Assay Corp.. It received FDA 510(k) clearance on 1981-04-08 under 510(k) number K810857. 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 KIT?

T3 UPTAKE KIT is a medical device that received FDA 510(k) clearance on 1981-04-08. The listed applicant is Immuno Assay Corp.. The 510(k) number is K810857.

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

T3 UPTAKE KIT received FDA 510(k) clearance on 1981-04-08, under 510(k) number K810857.

Who is the listed applicant for T3 UPTAKE KIT?

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

What is the FDA product code for T3 UPTAKE KIT?

The FDA product code for T3 UPTAKE KIT is KHQ.

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Other records listing Immuno Assay Corp. 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.

K833842RIA COAT DIGOXINK833745RIACOAT T-4K820089TSH (RIA) KITK820074CORTISOL (RIA) KITK811954COMBO-FER IRON DIAGNOSTICK811725TBG DIAGNOSTIC 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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