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FDA 510(k)

T3 UPTAKE DIAGNOSTIC KIT

K-Number: K821722 · 1982-06-24

ApplicantDiagnostic Reagents, Inc.
Decision Date1982-06-24
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T3 UPTAKE DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagents, Inc.. It received FDA 510(k) clearance on 1982-06-24 under 510(k) number K821722. 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 DIAGNOSTIC KIT?

T3 UPTAKE DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1982-06-24. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K821722.

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

T3 UPTAKE DIAGNOSTIC KIT received FDA 510(k) clearance on 1982-06-24, under 510(k) number K821722.

Who is the listed applicant for T3 UPTAKE DIAGNOSTIC KIT?

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

What is the FDA product code for T3 UPTAKE DIAGNOSTIC KIT?

The FDA product code for T3 UPTAKE DIAGNOSTIC KIT is KHQ.

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Other records listing Diagnostic Reagents, 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.

K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYK983812NAPA EIA ASSAYK983323DIGOXIN IMMUNOASSAYK983280VANCOMYCIN EIA ASSAYK983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSK973102LIDOCAINE EIA 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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