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FDA 510(k)

AMOXICILLIN/CLAVULANIC ACID 2/1

K-Number: K950328 · 1995-04-14

ApplicantAb Biodisk North America, Inc.
Decision Date1995-04-14
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AMOXICILLIN/CLAVULANIC ACID 2/1 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 1995-04-14 under 510(k) number K950328. 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 AMOXICILLIN/CLAVULANIC ACID 2/1?

AMOXICILLIN/CLAVULANIC ACID 2/1 is a medical device that received FDA 510(k) clearance on 1995-04-14. The listed applicant is Ab Biodisk North America, Inc.. The 510(k) number is K950328.

When did AMOXICILLIN/CLAVULANIC ACID 2/1 receive FDA 510(k) clearance?

AMOXICILLIN/CLAVULANIC ACID 2/1 received FDA 510(k) clearance on 1995-04-14, under 510(k) number K950328.

Who is the listed applicant for AMOXICILLIN/CLAVULANIC ACID 2/1?

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 AMOXICILLIN/CLAVULANIC ACID 2/1?

The FDA product code for AMOXICILLIN/CLAVULANIC ACID 2/1 is JWY.

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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.

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Related Devices (Code: JWY)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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