FDA 510(k)

ETEST MOXIFLOXACIN 0.002-32 UG/ML

K-Number: K093604 · 2010-08-25

Decision Date2010-08-25

Product CodeJWY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

ETEST MOXIFLOXACIN 0.002-32 UG/ML is the device name listed in this FDA 510(k) record. The listed applicant is Ab Biomerieux. It received FDA 510(k) clearance on 2010-08-25 under 510(k) number K093604. 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 ETEST MOXIFLOXACIN 0.002-32 UG/ML?

ETEST MOXIFLOXACIN 0.002-32 UG/ML is a medical device that received FDA 510(k) clearance on 2010-08-25. The listed applicant is Ab Biomerieux. The 510(k) number is K093604.

When did ETEST MOXIFLOXACIN 0.002-32 UG/ML receive FDA 510(k) clearance?

ETEST MOXIFLOXACIN 0.002-32 UG/ML received FDA 510(k) clearance on 2010-08-25, under 510(k) number K093604.

Who is the listed applicant for ETEST MOXIFLOXACIN 0.002-32 UG/ML?

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

What is the FDA product code for ETEST MOXIFLOXACIN 0.002-32 UG/ML?

The FDA product code for ETEST MOXIFLOXACIN 0.002-32 UG/ML is JWY.

Related Clinical Trials

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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Other records listing Ab Biomerieux as applicant

K082534ETEST VORICONAZOLE 0.002-32 UG/ML

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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.