GenePOC Carba
FDA 510(k) clearance K190275 · decided 2019-05-10
Clearance details
- K-number
- K190275
- Device name
- GenePOC Carba
- Applicant
- Genepoc, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-02-08
- Decision date
- 2019-05-10
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- PMY
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Quebec, CA
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Genepoc
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Acuitas AMR Gene Panel (K191288) | Opgen, Inc. | 2021-09-30 |
| Xpert Carba-R (K152614) | Cepheid | 2016-03-07 |
Recalls involving this device
No recalls on record reference this clearance.