Medical Device Manufacturer · US , Waukesha , WI

Gen-Probe Prodesse, Inc.

10 submissions · 10 cleared · Since 2010
10
Total
10
Cleared
0
Denied

Gen-Probe Prodesse, Inc. — FDA 510(k) Submissions

Gen-Probe Prodesse, Inc. has submitted 10 FDA 510(k) premarket notifications since 2010, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Respiratory Virus Panel Nucleic Acid Assay System, Human Metapneumovirus (hmpv) Rna Assay System, 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification, Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System, Parainfluenza Multiplex Nucleic Acid Assay . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
PRODESSE PROFAST+ ASSAY
K132237 · OQW 2009 H1n1 Influenza Virus... · Microbiology
Aug 2013 39d
PROPARAFLU+ ASSAY
K132238 · OOU Parainfluenza Multiplex... · Microbiology
Aug 2013 39d
PROADENO+ ASSAY
K132159 · OCC Respiratory Virus Panel... · Microbiology
Aug 2013 33d
PRO HMPV+ ASSAY
K132200 · OEM Human Metapneumovirus... · Microbiology
Aug 2013 29d
PRODESSE PROFLU+ ASSAY
K132129 · OCC Respiratory Virus Panel... · Microbiology
Aug 2013 30d
PROGASTRO SSCS ASSAY
K123274 · PCH Gastrointestinal Pathogen... · Microbiology
Jan 2013 89d
PRO HMPV+ ASSAY
K123838 · OEM Human Metapneumovirus... · Microbiology
Jan 2013 34d
PROFLU+ ASSAY
K110968 · OCC Respiratory Virus Panel... · Microbiology
Jun 2011 82d
PRODESSE PROADENO
K102952 · OCC Respiratory Virus Panel... · Microbiology
Dec 2010 59d
PROFAST+ ASSAY
K101855 · OQW 2009 H1n1 Influenza Virus... · Microbiology
Jul 2010 22d
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