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FDA 510(k)

ETEST VORICONAZOLE 0.002-32 UG/ML

K-Number: K082534 · 2009-11-02

ApplicantAb Biomerieux
Decision Date2009-11-02
Product CodeNGZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST VORICONAZOLE 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 2009-11-02 under 510(k) number K082534. The device is classified under product code NGZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETEST VORICONAZOLE 0.002-32 UG/ML?

ETEST VORICONAZOLE 0.002-32 UG/ML is a medical device that received FDA 510(k) clearance on 2009-11-02. The listed applicant is Ab Biomerieux. The 510(k) number is K082534.

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

ETEST VORICONAZOLE 0.002-32 UG/ML received FDA 510(k) clearance on 2009-11-02, under 510(k) number K082534.

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

The FDA product code for ETEST VORICONAZOLE 0.002-32 UG/ML is NGZ.

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

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.

K093604ETEST MOXIFLOXACIN 0.002-32 UG/ML

Related Devices (Code: NGZ)

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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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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