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FDA 510(k)

SYSTEM U3 FOR GENTAMICIN

K-Number: K983252 · 1998-11-20

ApplicantAb Biodisk North America, Inc.
Decision Date1998-11-20
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SYSTEM U3 FOR GENTAMICIN is the device name listed in this FDA 510(k) record. The listed applicant is Ab Biodisk North America, Inc.. It received FDA 510(k) clearance on 1998-11-20 under 510(k) number K983252. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEM U3 FOR GENTAMICIN?

SYSTEM U3 FOR GENTAMICIN is a medical device that received FDA 510(k) clearance on 1998-11-20. The listed applicant is Ab Biodisk North America, Inc.. The 510(k) number is K983252.

When did SYSTEM U3 FOR GENTAMICIN receive FDA 510(k) clearance?

SYSTEM U3 FOR GENTAMICIN received FDA 510(k) clearance on 1998-11-20, under 510(k) number K983252.

Who is the listed applicant for SYSTEM U3 FOR GENTAMICIN?

The FDA 510(k) record lists Ab Biodisk North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSTEM U3 FOR GENTAMICIN?

The FDA product code for SYSTEM U3 FOR GENTAMICIN is JWY.

Related Clinical Trials

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Other records listing Ab Biodisk North America, Inc. as applicant

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.

K950328AMOXICILLIN/CLAVULANIC ACID 2/1K935519ETEST FOR AMPICILLIN/SULBACTAM 2/1

Related Devices (Code: JWY)

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Official Source

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