Prodesse Proadeno
FDA 510(k) K102952 · Gen-Probe Prodesse, Inc.
510(k) numberK102952
Submission
- Device name
- Prodesse Proadeno
- Applicant
- Gen-Probe Prodesse, Inc.
Waukesha, WI, US - Received
- October 5, 2010
- Decision date
- December 3, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCC – Respiratory Virus Panel Nucleic Acid Assay System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Specialty
- Microbiology
A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of…
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|---|---|---|
| K132238 | Proparaflu+ AssayOOU · Special | 08/26/2013SE |
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| K132159 | Proadeno+ AssayOCC · Special | 08/14/2013SE |
| K132129 | Prodesse Proflu+ AssayOCC · Special | 08/09/2013SE |
| K123838 | Pro Hmpv+ AssayOEM · Special | 01/16/2013SE |
| K123274 | Progastro SSCS AssayPCH · Traditional | 01/16/2013SE |
| K110968 | Proflu+ AssayOCC · Traditional | 06/27/2011SE |
| K101855 | Profast+ AssayOQW · Traditional | 07/23/2010SE |
Questions and answers
When was Prodesse Proadeno cleared by the FDA?
Prodesse Proadeno (K102952) received a 510(k) decision of Substantially Equivalent on December 3, 2010, 59 days after the submission was received.
What is the product code of K102952?
The FDA product code is OCC – Respiratory Virus Panel Nucleic Acid Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3980.