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FDA 510(k)

AXSYM TOBRAMYCIN

K-Number: K941614 · 1994-08-18

ApplicantAbbott Laboratories
Decision Date1994-08-18
Product CodeLFW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AXSYM TOBRAMYCIN is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1994-08-18 under 510(k) number K941614. The device is classified under product code LFW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXSYM TOBRAMYCIN?

AXSYM TOBRAMYCIN is a medical device that received FDA 510(k) clearance on 1994-08-18. The listed applicant is Abbott Laboratories. The 510(k) number is K941614.

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

AXSYM TOBRAMYCIN received FDA 510(k) clearance on 1994-08-18, under 510(k) number K941614.

Who is the listed applicant for AXSYM TOBRAMYCIN?

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 TOBRAMYCIN?

The FDA product code for AXSYM TOBRAMYCIN is LFW.

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Related Devices (Code: LFW)

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.

K964670ROCHE COBAS-FP REAGENTS FOR TOBRAMYCINRoche Diagnostic Systems, Inc.K944371TOBRAMYCIN FPIA REAGENT SET AND CALIBRATORSigma Diagnostics, Inc.K912143CEDIA(R) TOBRAMYCIN ASSAYMicrogenics Corp.K900707MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATORInnotron of Oregon, Inc.K894531FPR TOBRAMYCIN KITColony Laboratories, Inc.K872562INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SETInnotron of Oregon, Inc.

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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