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)

ENTEROCOCCUS QUICKFISH BC

K-Number: K121991 · 2013-01-07

ApplicantAdvandx, Inc.
Decision Date2013-01-07
Product CodeOAH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENTEROCOCCUS 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 2013-01-07 under 510(k) number K121991. The device is classified under product code OAH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTEROCOCCUS QUICKFISH BC?

ENTEROCOCCUS QUICKFISH BC is a medical device that received FDA 510(k) clearance on 2013-01-07. The listed applicant is Advandx, Inc.. The 510(k) number is K121991.

When did ENTEROCOCCUS QUICKFISH BC receive FDA 510(k) clearance?

ENTEROCOCCUS QUICKFISH BC received FDA 510(k) clearance on 2013-01-07, under 510(k) number K121991.

Who is the listed applicant for ENTEROCOCCUS 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 ENTEROCOCCUS QUICKFISH BC?

The FDA product code for ENTEROCOCCUS QUICKFISH BC is OAH.

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 BCK113371STAPHYLOCOCCUS QUICKFISH BCK101558GNR TRAFFIC LIGHT PNA FISHK093024YEAST TRAFFIC LIGHT PNA FISHK092784C. ALBICANS/C. GLABRATA PNA FISHK092655C. ALBICANS PNA FISH

View all 20 devices →

Related Devices (Code: OAH)

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.

K083074AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KITAdvandx, Inc.K082612GBS PNA FISHAdvandx, Inc.K063127ENTEROCOCCUS FAECALIS 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.

↑