The following data is part of a premarket notification filed by Prodesse, Inc. with the FDA for Progastro Cd Assay.
| Device ID | K090239 |
| 510k Number | K090239 |
| Device Name: | PROGASTRO CD ASSAY |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | PRODESSE, INC. W229 N1870 WESTWOOD DR. Waukesha, WI 53186 |
| Contact | Kristine Schraufnagel |
| Correspondent | Kristine Schraufnagel PRODESSE, INC. W229 N1870 WESTWOOD DR. Waukesha, WI 53186 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-02 |
| Decision Date | 2009-04-16 |
| Summary: | summary |