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FDA 510(k)

YEAST TRAFFIC LIGHT PNA FISH

K-Number: K080719 · 2008-09-12

ApplicantAdvandx, Inc.
Decision Date2008-09-12
Product CodeJXB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

YEAST TRAFFIC LIGHT 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 2008-09-12 under 510(k) number K080719. The device is classified under product code JXB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the YEAST TRAFFIC LIGHT PNA FISH?

YEAST TRAFFIC LIGHT PNA FISH is a medical device that received FDA 510(k) clearance on 2008-09-12. The listed applicant is Advandx, Inc.. The 510(k) number is K080719.

When did YEAST TRAFFIC LIGHT PNA FISH receive FDA 510(k) clearance?

YEAST TRAFFIC LIGHT PNA FISH received FDA 510(k) clearance on 2008-09-12, under 510(k) number K080719.

Who is the listed applicant for YEAST TRAFFIC LIGHT 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 YEAST TRAFFIC LIGHT PNA FISH?

The FDA product code for YEAST TRAFFIC LIGHT PNA FISH is JXB.

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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: JXB)

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.

K062461C. ALBICANS PNA FISHAdvandx, Inc.K993554YEASTESTDiagnostic Markers, Inc.K943621RAPID YEAST PLUS SYSTEMInnovative Diagnostic Systems, Inc.K935124BACTICARD CANDIDARemel Co.K900112MICRORING YTMedical Wire & Equipment Co.K881925VITEK YEAST BIOCHEMICAL CARDVitek Systems, 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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