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FDA 510(k)

STAPHYLOCOCCUS QUICKFISH BC

K-Number: K113371 · 2012-04-03

ApplicantAdvandx, Inc.
Decision Date2012-04-03
Product CodeNXX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STAPHYLOCOCCUS QUICKFISH BC is the device name listed in this FDA 510(k) record. The listed applicant is Advandx, Inc.. It received FDA 510(k) clearance on 2012-04-03 under 510(k) number K113371. 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 STAPHYLOCOCCUS QUICKFISH BC?

STAPHYLOCOCCUS QUICKFISH BC is a medical device that received FDA 510(k) clearance on 2012-04-03. The listed applicant is Advandx, Inc.. The 510(k) number is K113371.

When did STAPHYLOCOCCUS QUICKFISH BC receive FDA 510(k) clearance?

STAPHYLOCOCCUS QUICKFISH BC received FDA 510(k) clearance on 2012-04-03, under 510(k) number K113371.

Who is the listed applicant for STAPHYLOCOCCUS QUICKFISH BC?

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 STAPHYLOCOCCUS QUICKFISH BC?

The FDA product code for STAPHYLOCOCCUS QUICKFISH BC is NXX.

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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 BCK101558GNR TRAFFIC LIGHT PNA FISHK093024YEAST TRAFFIC LIGHT PNA FISHK092784C. ALBICANS/C. GLABRATA PNA FISHK092655C. ALBICANS 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.

K092166S. AUREUS/CNS PNA FISH, MODEL KT005Advandx, 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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