Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

C. ALBICANS/C. GLABRATA PNA FISH

K-Number: K092784 · 2010-03-12

ApplicantAdvandx, Inc.
Decision Date2010-03-12
Product CodeNZS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

C. ALBICANS/C. GLABRATA 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 2010-03-12 under 510(k) number K092784. The device is classified under product code NZS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C. ALBICANS/C. GLABRATA PNA FISH?

C. ALBICANS/C. GLABRATA PNA FISH is a medical device that received FDA 510(k) clearance on 2010-03-12. The listed applicant is Advandx, Inc.. The 510(k) number is K092784.

When did C. ALBICANS/C. GLABRATA PNA FISH receive FDA 510(k) clearance?

C. ALBICANS/C. GLABRATA PNA FISH received FDA 510(k) clearance on 2010-03-12, under 510(k) number K092784.

Who is the listed applicant for C. ALBICANS/C. GLABRATA 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 C. ALBICANS/C. GLABRATA PNA FISH?

The FDA product code for C. ALBICANS/C. GLABRATA PNA FISH is NZS.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 FISHK092655C. ALBICANS PNA FISH

View all 20 devices →

Related Devices (Code: NZS)

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.

K093024YEAST TRAFFIC LIGHT PNA FISHAdvandx, Inc.K092655C. ALBICANS 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.

↑