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FDA 510(k)

ABBOTT IMX FREE T4

K-Number: K902834 · 1990-09-07

ApplicantAbbott Laboratories
Decision Date1990-09-07
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT IMX FREE T4 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1990-09-07 under 510(k) number K902834. 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 ABBOTT IMX FREE T4?

ABBOTT IMX FREE T4 is a medical device that received FDA 510(k) clearance on 1990-09-07. The listed applicant is Abbott Laboratories. The 510(k) number is K902834.

When did ABBOTT IMX FREE T4 receive FDA 510(k) clearance?

ABBOTT IMX FREE T4 received FDA 510(k) clearance on 1990-09-07, under 510(k) number K902834.

Who is the listed applicant for ABBOTT IMX FREE T4?

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

What is the FDA product code for ABBOTT IMX FREE T4?

The FDA product code for ABBOTT IMX FREE T4 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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