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 |