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FDA 510(k)

IN VITRO T-3 UPTAKE TEST

K-Number: K770480 · 1977-04-06

ApplicantClinical Assays, Inc.
Decision Date1977-04-06
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IN VITRO T-3 UPTAKE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Assays, Inc.. It received FDA 510(k) clearance on 1977-04-06 under 510(k) number K770480. 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 IN VITRO T-3 UPTAKE TEST?

IN VITRO T-3 UPTAKE TEST is a medical device that received FDA 510(k) clearance on 1977-04-06. The listed applicant is Clinical Assays, Inc.. The 510(k) number is K770480.

When did IN VITRO T-3 UPTAKE TEST receive FDA 510(k) clearance?

IN VITRO T-3 UPTAKE TEST received FDA 510(k) clearance on 1977-04-06, under 510(k) number K770480.

Who is the listed applicant for IN VITRO T-3 UPTAKE TEST?

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

What is the FDA product code for IN VITRO T-3 UPTAKE TEST?

The FDA product code for IN VITRO T-3 UPTAKE TEST is KHQ.

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Related Devices (Code: KHQ)

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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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