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FDA 510(k)

THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM

K-Number: K904816 · 1991-01-17

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1991-01-17
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1991-01-17 under 510(k) number K904816. 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 THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM?

THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM is a medical device that received FDA 510(k) clearance on 1991-01-17. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K904816.

When did THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM receive FDA 510(k) clearance?

THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM received FDA 510(k) clearance on 1991-01-17, under 510(k) number K904816.

Who is the listed applicant for THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM?

The FDA product code for THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM is CDX.

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Other records listing Bd Becton Dickinson Vacutainer Systems Preanalytic as applicant

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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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