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FDA 510(k)

E TEST FOR OFLOXACIN

K-Number: K946364 · 1995-05-02

ApplicantAb Biodisk
Decision Date1995-05-02
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

E TEST FOR OFLOXACIN is the device name listed in this FDA 510(k) record. The listed applicant is Ab Biodisk. It received FDA 510(k) clearance on 1995-05-02 under 510(k) number K946364. 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 E TEST FOR OFLOXACIN?

E TEST FOR OFLOXACIN is a medical device that received FDA 510(k) clearance on 1995-05-02. The listed applicant is Ab Biodisk. The 510(k) number is K946364.

When did E TEST FOR OFLOXACIN receive FDA 510(k) clearance?

E TEST FOR OFLOXACIN received FDA 510(k) clearance on 1995-05-02, under 510(k) number K946364.

Who is the listed applicant for E TEST FOR OFLOXACIN?

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

What is the FDA product code for E TEST FOR OFLOXACIN?

The FDA product code for E TEST FOR OFLOXACIN is JWY.

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Other records listing Ab Biodisk as applicant

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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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