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FDA 510(k)

ANALYTE T4-THYROXINE

K-Number: K800385 · 1980-03-19

ApplicantTechnicon Instruments Corp.
Decision Date1980-03-19
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ANALYTE T4-THYROXINE is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1980-03-19 under 510(k) number K800385. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANALYTE T4-THYROXINE?

ANALYTE T4-THYROXINE is a medical device that received FDA 510(k) clearance on 1980-03-19. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K800385.

When did ANALYTE T4-THYROXINE receive FDA 510(k) clearance?

ANALYTE T4-THYROXINE received FDA 510(k) clearance on 1980-03-19, under 510(k) number K800385.

Who is the listed applicant for ANALYTE T4-THYROXINE?

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

What is the FDA product code for ANALYTE T4-THYROXINE?

The FDA product code for ANALYTE T4-THYROXINE is CDX.

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Other records listing Technicon Instruments 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.

K914888TECHNICON CHEM 1(TM) SYST (GEN2 SYST)K914511TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOLK914025TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)K912616TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTESK912413CHEM-LINK DATA BASE MANAGERK903824DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY

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Related Devices (Code: CDX)

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.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, Inc.

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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