Acuitas AMR Gene Panel
FDA 510(k) clearance K191288 · decided 2021-09-30
Clearance details
- K-number
- K191288
- Device name
- Acuitas AMR Gene Panel
- Applicant
- Opgen, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-05-13
- Decision date
- 2021-09-30
- Days to decision
- 871 days
- Clearance type
- Traditional
- Product code
- PMY
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GenePOC Carba (K190275) | Genepoc, Inc. | 2019-05-10 |
| Xpert Carba-R (K152614) | Cepheid | 2016-03-07 |
Recalls involving this device
No recalls on record reference this clearance.