The following data is part of a premarket notification filed by Gen-probe Prodesse, Inc with the FDA for Pro Hmpv+ Assay.
| Device ID | K132200 |
| 510k Number | K132200 |
| Device Name: | PRO HMPV+ ASSAY |
| Classification | Human Metapneumovirus (hmpv) Rna 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 | OEM |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-16 |
| Decision Date | 2013-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045506367 | K132200 | 000 |