BD MAX Check-Points CPO
FDA 510(k) clearance K190613 · decided 2019-08-29
Clearance details
- K-number
- K190613
- Device name
- BD MAX Check-Points CPO
- Applicant
- Check-Points Health B.V.
- Decision
- Substantially Equivalent
- Date received
- 2019-03-11
- Decision date
- 2019-08-29
- Days to decision
- 171 days
- Clearance type
- Traditional
- Product code
- POC
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Wageningen, NL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Check-Points Health B.V.
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 |
|---|---|---|
| Xpert Carba-R (K261867) | Cepheid® | 2026-07-02 |
| Xpert Carba-R (K173263) | Cepheid | 2018-01-09 |
| Xpert Carba-R (K160901) | Cepheid | 2016-06-29 |
Recalls involving this device
No recalls on record reference this clearance.