The following data is part of a premarket notification filed by Gen-probe Prodesse, Inc. with the FDA for Progastro Sscs Assay.
| Device ID | K123274 |
| 510k Number | K123274 |
| Device Name: | PROGASTRO SSCS ASSAY |
| Classification | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System |
| Applicant | GEN-PROBE PRODESSE, INC. 20925 CROSSROADS CIRCLE Waukesha, WI 53186 |
| Contact | Karen Harrington |
| Correspondent | Karen Harrington GEN-PROBE PRODESSE, INC. 20925 CROSSROADS CIRCLE Waukesha, WI 53186 |
| Product Code | PCH |
| Subsequent Product Code | OOI |
| Subsequent Product Code | PCI |
| CFR Regulation Number | 866.3990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-19 |
| Decision Date | 2013-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045506350 | K123274 | 000 |