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FDA 510(k)

ABBOTT AXSYM DIGITOXIN (MODIFY)

K-Number: K963158 · 1996-09-10

ApplicantAbbott Laboratories
Decision Date1996-09-10
Product CodeLFM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABBOTT AXSYM DIGITOXIN (MODIFY) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1996-09-10 under 510(k) number K963158. 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 ABBOTT AXSYM DIGITOXIN (MODIFY)?

ABBOTT AXSYM DIGITOXIN (MODIFY) is a medical device that received FDA 510(k) clearance on 1996-09-10. The listed applicant is Abbott Laboratories. The 510(k) number is K963158.

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

ABBOTT AXSYM DIGITOXIN (MODIFY) received FDA 510(k) clearance on 1996-09-10, under 510(k) number K963158.

Who is the listed applicant for ABBOTT AXSYM DIGITOXIN (MODIFY)?

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 AXSYM DIGITOXIN (MODIFY)?

The FDA product code for ABBOTT AXSYM DIGITOXIN (MODIFY) 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.K954420AXSYM DIGITOXINAbbott 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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