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FDA 510(k)

GNR TRAFFIC LIGHT PNA FISH

K-Number: K101558 · 2010-12-16

ApplicantAdvandx, Inc.
Decision Date2010-12-16
Product CodeJSS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GNR 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 2010-12-16 under 510(k) number K101558. The device is classified under product code JSS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GNR TRAFFIC LIGHT PNA FISH?

GNR TRAFFIC LIGHT PNA FISH is a medical device that received FDA 510(k) clearance on 2010-12-16. The listed applicant is Advandx, Inc.. The 510(k) number is K101558.

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

GNR TRAFFIC LIGHT PNA FISH received FDA 510(k) clearance on 2010-12-16, under 510(k) number K101558.

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

The FDA product code for GNR TRAFFIC LIGHT PNA FISH is JSS.

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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 BCK093024YEAST TRAFFIC LIGHT PNA FISHK092784C. ALBICANS/C. GLABRATA PNA FISHK092655C. ALBICANS PNA FISH

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Related Devices (Code: JSS)

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 BCAdvandx, Inc.K092236E.COLI/P. AERUGINOSA PNA FISHAdvandx, Inc.K092393EK/P. AERUGINOSA PNA FISHAdvandx, Inc.K082068E. COLI PNA FISHAdvandx, Inc.K081433EK/P. AERUGINOSA PNA FISHAdvandx, Inc.K081309E.COLI/P. AERUGINOSA 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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