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FDA 510(k)

AXSYM DIGITOXIN

K-Number: K954420 · 1995-12-29

ApplicantAbbott Laboratories
Decision Date1995-12-29
Product CodeLFM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AXSYM 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 1995-12-29 under 510(k) number K954420. 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 AXSYM DIGITOXIN?

AXSYM DIGITOXIN is a medical device that received FDA 510(k) clearance on 1995-12-29. The listed applicant is Abbott Laboratories. The 510(k) number is K954420.

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

AXSYM DIGITOXIN received FDA 510(k) clearance on 1995-12-29, under 510(k) number K954420.

Who is the listed applicant for AXSYM 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 AXSYM DIGITOXIN?

The FDA product code for AXSYM 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 LaboratoriesK951631DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMSBayer Corp.

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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