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FDA 510(k)

AFFINITY FREE T4 TEST SYSTEM

K-Number: K912698 · 1991-10-07

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1991-10-07
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AFFINITY FREE T4 TEST SYSTEM 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 1991-10-07 under 510(k) number K912698. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFFINITY FREE T4 TEST SYSTEM?

AFFINITY FREE T4 TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1991-10-07. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K912698.

When did AFFINITY FREE T4 TEST SYSTEM receive FDA 510(k) clearance?

AFFINITY FREE T4 TEST SYSTEM received FDA 510(k) clearance on 1991-10-07, under 510(k) number K912698.

Who is the listed applicant for AFFINITY FREE T4 TEST SYSTEM?

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 AFFINITY FREE T4 TEST SYSTEM?

The FDA product code for AFFINITY FREE T4 TEST SYSTEM is CEC.

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Related Devices (Code: CEC)

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.

K240273Access Free T4Beckman Coulter, Inc.K220456Elecsys FT4 IVRoche DiagnosticsK182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.K181233Elecsys FT4 IIIRoche DiagnosticsK173122Abbott Architect Free T4Abbott LaboratoriesK152422FREND™ Free T4 Test SystemNanoentek USA, 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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