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FDA 510(k)

SERUM T4 BY ENZYME IMMUNOASSAY

K-Number: K802573 · 1980-11-24

ApplicantWorthington Diagnostic Systems
Decision Date1980-11-24
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM T4 BY ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Worthington Diagnostic Systems. It received FDA 510(k) clearance on 1980-11-24 under 510(k) number K802573. 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 SERUM T4 BY ENZYME IMMUNOASSAY?

SERUM T4 BY ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1980-11-24. The listed applicant is Worthington Diagnostic Systems. The 510(k) number is K802573.

When did SERUM T4 BY ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

SERUM T4 BY ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1980-11-24, under 510(k) number K802573.

Who is the listed applicant for SERUM T4 BY ENZYME IMMUNOASSAY?

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

What is the FDA product code for SERUM T4 BY ENZYME IMMUNOASSAY?

The FDA product code for SERUM T4 BY ENZYME IMMUNOASSAY is CDX.

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Other records listing Worthington Diagnostic Systems 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.

K833708COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTEK832748COMPUR* EASYTOUCH TOTAL BILIRUBINK832427EASYTOUCH TROMBOPLASTIN REAGENTK832785COMPUR* EASY TOUCH URIC ACID REAGENTK832749EASYTOUCH BUN REAGENT SETK832750EASYTOUCH HEMOGLOBIN REAGENT

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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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