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FDA 510(k)

AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT

K-Number: K083074 · 2009-07-24

ApplicantAdvandx, Inc.
Decision Date2009-07-24
Product CodeOAH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Advandx, Inc.. It received FDA 510(k) clearance on 2009-07-24 under 510(k) number K083074. The device is classified under product code OAH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT?

AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT is a medical device that received FDA 510(k) clearance on 2009-07-24. The listed applicant is Advandx, Inc.. The 510(k) number is K083074.

When did AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT receive FDA 510(k) clearance?

AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT received FDA 510(k) clearance on 2009-07-24, under 510(k) number K083074.

Who is the listed applicant for AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT?

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 AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT?

The FDA product code for AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT is OAH.

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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: OAH)

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.

K121991ENTEROCOCCUS QUICKFISH BCAdvandx, Inc.K082612GBS PNA FISHAdvandx, Inc.K063127ENTEROCOCCUS FAECALIS 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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