510(k) K101855
- Device
- PROFAST+ ASSAY
- Applicant
- GEN-PROBE PRODESSE, INC
- 510(k) number
- K101855
- Product code
- OQW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-07-23
- Date received
- 2010-07-01
- Regulation
- 866.3332
- Classification name
- 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAREN HARRINGTON
- Address
- W229n1870 Westwood Dr. Waukesha WI US 53186 53186
FDA Registration Numbers#
- 3013019728
- 3038610665
- 3008632402
Source Documents#
Other 510(k) Records For Product Code OQW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132237 | PRODESSE PROFAST+ ASSAY | Gen-Probe Prodesse, Inc. | 2013-08-26 |
| K130551 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | Centers for Disease Control and Prevention | 2013-05-22 |
| K123905 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | Centers for Disease Control and Prevention | 2013-01-14 |
| K120911 | XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) | Cepheid | 2012-05-18 |
| K111778 | JBAIDS INFLUENZA A SUBTYPING KIT | U.S Army Medical Materiel Development Activity | 2011-09-13 |
| K111507 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | Centers for Disease Control and Prevention | 2011-08-23 |
| K103766 | XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0 | Cepheid | 2011-04-21 |
| K101564 | CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL | Centers for Disease Control and Prevention | 2010-06-22 |
| K100148 | SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 | Focus Diagnostics, Inc. | 2010-05-24 |
Legacy Summary#
summary
FDA Review#
Decision Summary