The following data is part of a premarket notification filed by Opgen, Inc. with the FDA for Acuitas Amr Gene Panel.
| Device ID | K191288 |
| 510k Number | K191288 |
| Device Name: | Acuitas AMR Gene Panel |
| Classification | System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony |
| Applicant | OpGen, Inc. 9717 Key West Avenue Suite 100 Rockville, MD 20850 |
| Contact | Autumn Collasius |
| Correspondent | Randy Prebula Hogan Lovells, US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004 |
| Product Code | PMY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-13 |
| Decision Date | 2021-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 01812125010081 | K191288 | 000 |
| 10812125010027 | K191288 | 000 |
| 10812125010041 | K191288 | 000 |
| 10812125010058 | K191288 | 000 |
| 20812125010062 | K191288 | 000 |
| 20812125010079 | K191288 | 000 |
| 20812125010086 | K191288 | 000 |
| 04260364751000 | K191288 | 000 |
| 04260364751017 | K191288 | 000 |
| 04260364751024 | K191288 | 000 |
| 04260364751031 | K191288 | 000 |
| 00812125010013 | K191288 | 000 |
| 00812125010020 | K191288 | 000 |
| 00812125010044 | K191288 | 000 |
| 00812125010051 | K191288 | 000 |
| 01812125010067 | K191288 | 000 |
| 01812125010074 | K191288 | 000 |
| 10812125010010 | K191288 | 000 |