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FDA 510(k)

ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE

K-Number: K922991 · 1992-08-27

ApplicantAbbott Laboratories
Decision Date1992-08-27
Product CodeLGS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1992-08-27 under 510(k) number K922991. The device is classified under product code LGS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE?

ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE is a medical device that received FDA 510(k) clearance on 1992-08-27. The listed applicant is Abbott Laboratories. The 510(k) number is K922991.

When did ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE receive FDA 510(k) clearance?

ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE received FDA 510(k) clearance on 1992-08-27, under 510(k) number K922991.

Who is the listed applicant for ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE?

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 TDX/TDXFLX AND TDXFLX THEOPHYLLINE?

The FDA product code for ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE is LGS.

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Related Devices (Code: LGS)

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.

K070810ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)Biokit, S.A.K955567INNOFLUOR THEOPHYLLINE ASSAY SYSTEMOxis Intl., Inc.K953016AXSYM THEOPHYLLINE IIAbbott LaboratoriesK951169CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAYCiba Corning Diagnostics Corp.K942991QMS THEOPHYLLINE CSSeradyn, Inc.K932127TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL IIAbbott Laboratories

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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