The following data is part of a premarket notification filed by Gen-probe Prodesse, Inc with the FDA for Profast+ Assay.
| Device ID | K101855 |
| 510k Number | K101855 |
| Device Name: | PROFAST+ ASSAY |
| Classification | 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification |
| Applicant | GEN-PROBE PRODESSE, INC W229 N1870 WESTWOOD DR Waukesha, WI 53186 |
| Contact | Karen Harrington |
| Correspondent | Karen Harrington GEN-PROBE PRODESSE, INC W229 N1870 WESTWOOD DR Waukesha, WI 53186 |
| Product Code | OQW |
| CFR Regulation Number | 866.3332 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-01 |
| Decision Date | 2010-07-23 |
| Summary: | summary |