The following data is part of a premarket notification filed by Gen-probe Prodesse, Inc. with the FDA for Prodesse Proflu+ Assay.
| Device ID | K132129 |
| 510k Number | K132129 |
| Device Name: | PRODESSE PROFLU+ ASSAY |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | GEN-PROBE PRODESSE, INC. 20925 CROSSROADS CIRCLE Waukesha, WI 53186 |
| Contact | Emily Ziegler |
| Correspondent | Emily Ziegler GEN-PROBE PRODESSE, INC. 20925 CROSSROADS CIRCLE Waukesha, WI 53186 |
| Product Code | OCC |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-10 |
| Decision Date | 2013-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045506343 | K132129 | 000 |
| 15420045506336 | K132129 | 000 |
| 15420045506329 | K132129 | 000 |