510(k) DEN040002
- Device
- NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970
- Applicant
- Perkinelmer Life Sciences, Inc.
- 510(k) number
- DEN040002
- Product code
- NQL
- Decision
- Unknown (DENG)
- Decision date
- 2004-08-24
- Date received
- 2004-07-02
- 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
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- CINDY LLOYD
- Address
- 3985 Eastern Rd. Norton OH US 44203 44203
FDA Registration Numbers#
- 8043909
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NQL#
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|---|---|---|---|
| K193103 | NeoBase 2 Non-derivatized MSMS Kit | Perkinelmer, Inc. | 2020-02-07 |
| 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 |