Company ยท US
Gen-Probe Prodesse, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2013. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 4 |
| OEM | Human Metapneumovirus (Hmpv) Rna Assay System | 2 |
| OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification | 2 |
| OOU | Parainfluenza Multiplex Nucleic Acid Assay | 1 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 26, 2013 | K132238 | PROPARAFLU+ ASSAY Gen-Probe Prodesse, Inc. | OOU |
| Aug 26, 2013 | K132237 | PRODESSE PROFAST+ ASSAY Gen-Probe Prodesse, Inc. | OQW |
| Aug 14, 2013 | K132200 | PRO HMPV+ ASSAY Gen-Probe Prodesse, Inc. | OEM |
| Aug 14, 2013 | K132159 | PROADENO+ ASSAY Gen-Probe Prodesse, Inc. | OCC |
| Aug 9, 2013 | K132129 | PRODESSE PROFLU+ ASSAY Gen-Probe Prodesse, Inc. | OCC |
| Jan 16, 2013 | K123838 | PRO HMPV+ ASSAY Gen-Probe Prodesse, Inc. | OEM |
| Jan 16, 2013 | K123274 | PROGASTRO SSCS ASSAY Gen-Probe Prodesse, Inc. | PCH |
| Jun 27, 2011 | K110968 | PROFLU+ ASSAY Gen-Probe Prodesse, Inc. | OCC |
| Dec 3, 2010 | K102952 | PRODESSE PROADENO Gen-Probe Prodesse, Inc. | OCC |
| Jul 23, 2010 | K101855 | PROFAST+ ASSAY Gen-Probe Prodesse, Inc. | OQW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||