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)

PRODESSE PROADENO

K-Number: K102952 · 2010-12-03

ApplicantGen-Probe Prodesse, Inc.
Decision Date2010-12-03
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PRODESSE PROADENO is the device name listed in this FDA 510(k) record. The listed applicant is Gen-Probe Prodesse, Inc.. It received FDA 510(k) clearance on 2010-12-03 under 510(k) number K102952. 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 PRODESSE PROADENO?

PRODESSE PROADENO is a medical device that received FDA 510(k) clearance on 2010-12-03. The listed applicant is Gen-Probe Prodesse, Inc.. The 510(k) number is K102952.

When did PRODESSE PROADENO receive FDA 510(k) clearance?

PRODESSE PROADENO received FDA 510(k) clearance on 2010-12-03, under 510(k) number K102952.

Who is the listed applicant for PRODESSE PROADENO?

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

What is the FDA product code for PRODESSE PROADENO?

The FDA product code for PRODESSE PROADENO 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 Gen-Probe 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.

K132238PROPARAFLU+ ASSAYK132237PRODESSE PROFAST+ ASSAYK132200PRO HMPV+ ASSAYK132159PROADENO+ ASSAYK132129PRODESSE PROFLU+ ASSAYK123274PROGASTRO SSCS ASSAY

View all 10 devices →

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.

↑