The following data is part of a premarket notification filed by Neumodx Molecular, Inc. with the FDA for Neumodx Gbs Assay.
| Device ID | K173725 |
| 510k Number | K173725 |
| Device Name: | NeuMoDx GBS Assay |
| Classification | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| Applicant | NeuMoDx Molecular, Inc. 1250 Eisenhower Place Ann Arbor, MI 48108 |
| Contact | Kay Fuller |
| Correspondent | Kay Fuller Medical Device Regulatory Solutions, LLC 230 Collingwood Dr. Suite 260 Ann Arbor, MI 48103 |
| Product Code | NJR |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-05 |
| Decision Date | 2018-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10814278020045 | K173725 | 000 |