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FDA 510(k)

TDX DIGITOXIN

K-Number: K842280 · 1984-08-16

ApplicantAbbott Laboratories
Decision Date1984-08-16
Product CodeLFM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TDX DIGITOXIN is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1984-08-16 under 510(k) number K842280. The device is classified under product code LFM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDX DIGITOXIN?

TDX DIGITOXIN is a medical device that received FDA 510(k) clearance on 1984-08-16. The listed applicant is Abbott Laboratories. The 510(k) number is K842280.

When did TDX DIGITOXIN receive FDA 510(k) clearance?

TDX DIGITOXIN received FDA 510(k) clearance on 1984-08-16, under 510(k) number K842280.

Who is the listed applicant for TDX DIGITOXIN?

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 TDX DIGITOXIN?

The FDA product code for TDX DIGITOXIN is LFM.

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Related Devices (Code: LFM)

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.

K062024DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGEDade Behring, Inc.K012112RANDOX DIGITOXINRandox Laboratories, Ltd.K990251DGTX FLEX REAGENT CARTRIDGE, MODEL DF36Dade Behring, Inc.K970546ACS DIGITOXINChiron Diagnostics Corp.K963158ABBOTT AXSYM DIGITOXIN (MODIFY)Abbott LaboratoriesK954420AXSYM DIGITOXINAbbott 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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