PRODESSE PROFAST+ ASSAY— 510(k) K132237
Substantially EquivalentGen-Probe Prodesse, Inc.
FDA 510(k) clearance K132237 for PRODESSE PROFAST+ ASSAY, Substantially Equivalent on 2013-08-26. Applicant: Gen-Probe Prodesse, Inc.. Device class: 2.
Clearance details
- Applicant
- Gen-Probe Prodesse, Inc.
- Product code
- Code OQW
- Device class
- Class 2
- Regulation
- 21 CFR 866.3332
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Waukesha, WI, US
Recent devices under product code OQW
view all- K130551 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
- K123905 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
- K120911 — XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)
- K111778 — JBAIDS INFLUENZA A SUBTYPING KIT
- K111507 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
More clearances from Gen-Probe Prodesse, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.