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)

MODIFICATION TO PROFLU+ ASSAY

K-Number: K092500 · 2009-08-20

ApplicantProdesse, Inc.
Decision Date2009-08-20
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO PROFLU+ ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Prodesse, Inc.. It received FDA 510(k) clearance on 2009-08-20 under 510(k) number K092500. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO PROFLU+ ASSAY?

MODIFICATION TO PROFLU+ ASSAY is a medical device that received FDA 510(k) clearance on 2009-08-20. The listed applicant is Prodesse, Inc.. The 510(k) number is K092500.

When did MODIFICATION TO PROFLU+ ASSAY receive FDA 510(k) clearance?

MODIFICATION TO PROFLU+ ASSAY received FDA 510(k) clearance on 2009-08-20, under 510(k) number K092500.

Who is the listed applicant for MODIFICATION TO PROFLU+ ASSAY?

The FDA 510(k) record lists Prodesse, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO PROFLU+ ASSAY?

The FDA product code for MODIFICATION TO PROFLU+ ASSAY is OCC.

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 Prodesse, 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.

K091053PROPARAFLU+ASSAYK090239PROGASTRO CD ASSAYK082688PRO HMPV+ ASSAYK081030MODIFICATION TO PROFLU+ ASSAYK073029PROFLU+ ASSAY

Related Devices (Code: OCC)

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.

K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.K242613NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc.K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, 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.

↑