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