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FDA 510(k)

REAGENT SYSTEM, THYROXINE, ARIA

K-Number: K770733 · 1977-06-24

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1977-06-24
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT SYSTEM, THYROXINE, ARIA 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 1977-06-24 under 510(k) number K770733. 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 REAGENT SYSTEM, THYROXINE, ARIA?

REAGENT SYSTEM, THYROXINE, ARIA is a medical device that received FDA 510(k) clearance on 1977-06-24. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K770733.

When did REAGENT SYSTEM, THYROXINE, ARIA receive FDA 510(k) clearance?

REAGENT SYSTEM, THYROXINE, ARIA received FDA 510(k) clearance on 1977-06-24, under 510(k) number K770733.

Who is the listed applicant for REAGENT SYSTEM, THYROXINE, ARIA?

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 REAGENT SYSTEM, THYROXINE, ARIA?

The FDA product code for REAGENT SYSTEM, THYROXINE, ARIA is CDX.

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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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