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FDA 510(k)

E. COLI PNA FISH

K-Number: K082068 · 2009-06-25

ApplicantAdvandx, Inc.
Decision Date2009-06-25
Product CodeJSS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

E. COLI 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 2009-06-25 under 510(k) number K082068. 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 E. COLI PNA FISH?

E. COLI PNA FISH is a medical device that received FDA 510(k) clearance on 2009-06-25. The listed applicant is Advandx, Inc.. The 510(k) number is K082068.

When did E. COLI PNA FISH receive FDA 510(k) clearance?

E. COLI PNA FISH received FDA 510(k) clearance on 2009-06-25, under 510(k) number K082068.

Who is the listed applicant for E. COLI 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 E. COLI PNA FISH?

The FDA product code for E. COLI PNA FISH is JSS.

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

View all 20 devices →

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.K101558GNR TRAFFIC LIGHT PNA FISHAdvandx, Inc.K092236E.COLI/P. AERUGINOSA PNA FISHAdvandx, Inc.K092393EK/P. AERUGINOSA 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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