510(k) K193103
- Device
- NeoBase 2 Non-derivatized MSMS Kit
- Applicant
- PerkinElmer Inc.
- 510(k) number
- K193103
- Product code
- NQL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-02-07
- Date received
- 2019-11-08
- Regulation
- 862.1055
- Classification name
- System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Eva Nalian
- Address
- 940 Winter St. Waltham MA US 02451 02451
FDA Registration Numbers#
- 8043909
Source Documents#
Other 510(k) Records For Product Code NQL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K173568 | NeoBase 2 Non-derivatized MSMS Kit | Wallac Oy, Subsidiary of Perkinelmer, Inc. | 2018-09-04 |
| K093916 | NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U | Perkinelmer, Inc. | 2010-08-23 |
| K083130 | NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 | Perkinelmer, Inc. | 2009-07-09 |
| DEN040002 | NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970 | Perkinelmer Life Sciences, Inc. | 2004-08-24 |
Legacy Summary#
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FDA Review#
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