NeoBase 2 Non-derivatized MSMS Kit
FDA 510(k) clearance K193103 · decided 2020-02-07
Clearance details
- K-number
- K193103
- Device name
- NeoBase 2 Non-derivatized MSMS Kit
- Applicant
- Perkinelmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-11-08
- Decision date
- 2020-02-07
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- NQL
- Device class
- 2
- Regulation number
- 862.1055
- 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 |
|---|---|---|
| NeoBase 2 Non-derivatized MSMS Kit (K173568) | Wallac Oy, Subsidiary of Perkinelmer, Inc. | 2018-09-04 |
| NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U (K093916) | Perkinelmer, Inc. | 2010-08-23 |
| NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 (K083130) | Perkinelmer, Inc. | 2009-07-09 |
| NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970 (DEN040002) | Perkinelmer Life Sciences, Inc. | 2004-08-24 |
Recalls involving this device
No recalls on record reference this clearance.