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FDA 510(k)

AXSYM VANCOMYCIN II

K-Number: K955851 · 1996-05-09

ApplicantAbbott Laboratories
Decision Date1996-05-09
Product CodeLEH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AXSYM VANCOMYCIN II is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1996-05-09 under 510(k) number K955851. The device is classified under product code LEH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXSYM VANCOMYCIN II?

AXSYM VANCOMYCIN II is a medical device that received FDA 510(k) clearance on 1996-05-09. The listed applicant is Abbott Laboratories. The 510(k) number is K955851.

When did AXSYM VANCOMYCIN II receive FDA 510(k) clearance?

AXSYM VANCOMYCIN II received FDA 510(k) clearance on 1996-05-09, under 510(k) number K955851.

Who is the listed applicant for AXSYM VANCOMYCIN II?

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 VANCOMYCIN II?

The FDA product code for AXSYM VANCOMYCIN II is LEH.

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Related Devices (Code: LEH)

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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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