ProParaFlu+ Assay
FDA 510(k) K153223 · Hologic, Inc.
510(k) numberK153223
Submission
- Device name
- ProParaFlu+ Assay
- Applicant
- Hologic, Inc.
San Diego, CA, US - Received
- November 6, 2015
- Decision date
- December 9, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OOU – Parainfluenza Multiplex Nucleic Acid Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Specialty
- Microbiology
A parainfluenza multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract…
Other 510(k)s with product code OOU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172282 | Panther Fusion Paraflu AssayOOU · Traditional | Hologic, Inc. | 10/23/2017SE |
| K141927 | Lyra Parainfluenza Virus AssayOOU · Traditional | Quidel Corporation | 10/09/2014SE |
| K132238 | Proparaflu+ AssayOOU · Special | Gen-Probe Prodesse, Inc. | 08/26/2013SE |
| K091053 | Proparaflu+AssayOOU · Traditional | Prodesse, Inc. | 11/20/2009SE |
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Questions and answers
When was ProParaFlu+ Assay cleared by the FDA?
ProParaFlu+ Assay (K153223) received a 510(k) decision of Substantially Equivalent on December 9, 2015, 33 days after the submission was received.
What is the product code of K153223?
The FDA product code is OOU – Parainfluenza Multiplex Nucleic Acid Assay, a Class II (moderate risk) device regulated under 21 CFR 866.3980.