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FDA 510(k)

ACA THYROXINE UPTAKE ANALYTICAL TEST

K-Number: K833703 · 1984-01-30

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1984-01-30
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACA THYROXINE UPTAKE ANALYTICAL TEST is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1984-01-30 under 510(k) number K833703. 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 ACA THYROXINE UPTAKE ANALYTICAL TEST?

ACA THYROXINE UPTAKE ANALYTICAL TEST is a medical device that received FDA 510(k) clearance on 1984-01-30. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K833703.

When did ACA THYROXINE UPTAKE ANALYTICAL TEST receive FDA 510(k) clearance?

ACA THYROXINE UPTAKE ANALYTICAL TEST received FDA 510(k) clearance on 1984-01-30, under 510(k) number K833703.

Who is the listed applicant for ACA THYROXINE UPTAKE ANALYTICAL TEST?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACA THYROXINE UPTAKE ANALYTICAL TEST?

The FDA product code for ACA THYROXINE UPTAKE ANALYTICAL TEST is KHQ.

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Other records listing E.I. Dupont DE Nemours & Co., 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.

K951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYK953724CRONEX RADIATION THERAPY CASSETTEK953725CRONEX RADIATION THERAPY VERIFICATION CASSETTEK951441DUPONT ACA DIGOXIN (DGN A) METHODK950137URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGEK950136URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE

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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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