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FDA 510(k)

S. AUREUS/CNS PNA FISH, MODEL KT005

K-Number: K092166 · 2009-11-23

ApplicantAdvandx, Inc.
Decision Date2009-11-23
Product CodeNXX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

S. AUREUS/CNS PNA FISH, MODEL KT005 is the device name listed in this FDA 510(k) record. The listed applicant is Advandx, Inc.. It received FDA 510(k) clearance on 2009-11-23 under 510(k) number K092166. The device is classified under product code NXX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S. AUREUS/CNS PNA FISH, MODEL KT005?

S. AUREUS/CNS PNA FISH, MODEL KT005 is a medical device that received FDA 510(k) clearance on 2009-11-23. The listed applicant is Advandx, Inc.. The 510(k) number is K092166.

When did S. AUREUS/CNS PNA FISH, MODEL KT005 receive FDA 510(k) clearance?

S. AUREUS/CNS PNA FISH, MODEL KT005 received FDA 510(k) clearance on 2009-11-23, under 510(k) number K092166.

Who is the listed applicant for S. AUREUS/CNS PNA FISH, MODEL KT005?

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

What is the FDA product code for S. AUREUS/CNS PNA FISH, MODEL KT005?

The FDA product code for S. AUREUS/CNS PNA FISH, MODEL KT005 is NXX.

Related Clinical Trials

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Other records listing Advandx, 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.

K123418GRAM-NEGATIVE QUICKFISH BCK121991ENTEROCOCCUS QUICKFISH BCK113371STAPHYLOCOCCUS QUICKFISH BCK101558GNR TRAFFIC LIGHT PNA FISHK093024YEAST TRAFFIC LIGHT PNA FISHK092784C. ALBICANS/C. GLABRATA PNA FISH

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Related Devices (Code: NXX)

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.

K113371STAPHYLOCOCCUS QUICKFISH BCAdvandx, Inc.K091827S. AUREUS PNA FISHAdvandx, Inc.K060099S. AUREUS PNA FISHAdvandx, Inc.

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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