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FDA 510(k)

'TDXFLX ANALYZER

K-Number: K904226 · 1990-10-29

ApplicantAbbott Laboratories
Decision Date1990-10-29
Product CodeLCQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

'TDXFLX ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1990-10-29 under 510(k) number K904226. The device is classified under product code LCQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 'TDXFLX ANALYZER?

'TDXFLX ANALYZER is a medical device that received FDA 510(k) clearance on 1990-10-29. The listed applicant is Abbott Laboratories. The 510(k) number is K904226.

When did 'TDXFLX ANALYZER receive FDA 510(k) clearance?

'TDXFLX ANALYZER received FDA 510(k) clearance on 1990-10-29, under 510(k) number K904226.

Who is the listed applicant for 'TDXFLX ANALYZER?

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 'TDXFLX ANALYZER?

The FDA product code for 'TDXFLX ANALYZER is LCQ.

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Related Devices (Code: LCQ)

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.

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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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