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FDA 510(k)

S. AUREUS PNA FISH

K-Number: K091827 · 2009-08-18

ApplicantAdvandx, Inc.
Decision Date2009-08-18
Product CodeNXX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

S. AUREUS PNA FISH is the device name listed in this FDA 510(k) record. The listed applicant is Advandx, Inc.. It received FDA 510(k) clearance on 2009-08-18 under 510(k) number K091827. 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 PNA FISH?

S. AUREUS PNA FISH is a medical device that received FDA 510(k) clearance on 2009-08-18. The listed applicant is Advandx, Inc.. The 510(k) number is K091827.

When did S. AUREUS PNA FISH receive FDA 510(k) clearance?

S. AUREUS PNA FISH received FDA 510(k) clearance on 2009-08-18, under 510(k) number K091827.

Who is the listed applicant for S. AUREUS PNA FISH?

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 PNA FISH?

The FDA product code for S. AUREUS PNA FISH is NXX.

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 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.K092166S. AUREUS/CNS PNA FISH, MODEL KT005Advandx, 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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