SEEKER System
FDA 510(k) clearance DEN150035 · decided 2017-02-03
Clearance details
- K-number
- DEN150035
- Device name
- SEEKER System
- Applicant
- Baebies, Inc.
- Decision
- Unknown
- Date received
- 2015-08-05
- Decision date
- 2017-02-03
- Days to decision
- 548 days
- Clearance type
- Direct
- Product code
- PQW
- Device class
- 2
- Regulation number
- 862.1488
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Durham, NC, 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 |
|---|---|---|
| NeoLSD MSMS Kit (K190266) | Perkinelmer, Inc. | 2019-05-03 |
| NeoLSD MSMS kit (K173829) | Wallac Oy, A Subsidiary of Perkinelmer | 2018-07-18 |
Recalls involving this device
No recalls on record reference this clearance.