The following data is part of a premarket notification filed by Prodesse, Inc. with the FDA for Proparaflu+assay.
| Device ID | K091053 |
| 510k Number | K091053 |
| Device Name: | PROPARAFLU+ASSAY |
| Classification | Parainfluenza Multiplex Nucleic Acid Assay |
| Applicant | PRODESSE, INC. W229 N1870 WESTWOOD DR. Waukesha, WI 53186 |
| Contact | Karen Harrington |
| Correspondent | Karen Harrington PRODESSE, INC. W229 N1870 WESTWOOD DR. Waukesha, WI 53186 |
| Product Code | OOU |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-13 |
| Decision Date | 2009-11-20 |
| Summary: | summary |