The following data is part of a premarket notification filed by Micronics, Inc with the FDA for Pannat Stec Test.
| Device ID | K173330 |
| 510k Number | K173330 |
| Device Name: | PanNAT STEC Test |
| Classification | Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System |
| Applicant | Micronics, Inc 8464 154th Ave NE Redmond, WA 98052 |
| Contact | Karen Hedine |
| Correspondent | Karen Hedine Micronics, Inc 8464 154th Ave NE Redmond, WA 98052 |
| Product Code | PCI |
| Subsequent Product Code | OOI |
| Subsequent Product Code | PCH |
| CFR Regulation Number | 866.3990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-23 |
| Decision Date | 2018-06-01 |
| Summary: | summary |