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FDA 510(k)

VISTA THYROXINE UPTAKE ASSAY

K-Number: K923676 · 1992-10-09

ApplicantSyva Co.
Decision Date1992-10-09
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VISTA THYROXINE UPTAKE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1992-10-09 under 510(k) number K923676. 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 VISTA THYROXINE UPTAKE ASSAY?

VISTA THYROXINE UPTAKE ASSAY is a medical device that received FDA 510(k) clearance on 1992-10-09. The listed applicant is Syva Co.. The 510(k) number is K923676.

When did VISTA THYROXINE UPTAKE ASSAY receive FDA 510(k) clearance?

VISTA THYROXINE UPTAKE ASSAY received FDA 510(k) clearance on 1992-10-09, under 510(k) number K923676.

Who is the listed applicant for VISTA THYROXINE UPTAKE ASSAY?

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

What is the FDA product code for VISTA THYROXINE UPTAKE ASSAY?

The FDA product code for VISTA THYROXINE UPTAKE ASSAY is KHQ.

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Other records listing Syva Co. 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.

K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULK012257EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229K011947EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229ULK011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

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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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