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FDA 510(k)

ABBOTT IMX T4

K-Number: K925110 · 1993-01-26

ApplicantAbbott Laboratories
Decision Date1993-01-26
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT IMX 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 1993-01-26 under 510(k) number K925110. 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 ABBOTT IMX T4?

ABBOTT IMX T4 is a medical device that received FDA 510(k) clearance on 1993-01-26. The listed applicant is Abbott Laboratories. The 510(k) number is K925110.

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

ABBOTT IMX T4 received FDA 510(k) clearance on 1993-01-26, under 510(k) number K925110.

Who is the listed applicant for ABBOTT IMX 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 T4?

The FDA product code for ABBOTT IMX T4 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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