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FDA 510(k)

GRAM-NEGATIVE QUICKFISH BC

K-Number: K123418 · 2013-07-21

ApplicantAdvandx, Inc.
Decision Date2013-07-21
Product CodeJSS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GRAM-NEGATIVE 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 2013-07-21 under 510(k) number K123418. 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 GRAM-NEGATIVE QUICKFISH BC?

GRAM-NEGATIVE QUICKFISH BC is a medical device that received FDA 510(k) clearance on 2013-07-21. The listed applicant is Advandx, Inc.. The 510(k) number is K123418.

When did GRAM-NEGATIVE QUICKFISH BC receive FDA 510(k) clearance?

GRAM-NEGATIVE QUICKFISH BC received FDA 510(k) clearance on 2013-07-21, under 510(k) number K123418.

Who is the listed applicant for GRAM-NEGATIVE 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 GRAM-NEGATIVE QUICKFISH BC?

The FDA product code for GRAM-NEGATIVE QUICKFISH BC 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.

K121991ENTEROCOCCUS QUICKFISH BCK113371STAPHYLOCOCCUS 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: 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.

K101558GNR TRAFFIC LIGHT PNA FISHAdvandx, 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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