Neobase Non-Derivatized MSMS Kit Model 3040-001U
FDA 510(k) K093916 · Perkinelmer, Inc.
Submission
- Device name
- Neobase Non-Derivatized MSMS Kit Model 3040-001U
- Applicant
- Perkinelmer, Inc.
Indianapolis, IN, US - Received
- December 22, 2009
- Decision date
- August 23, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQL – System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1055
- Specialty
- Clinical Chemistry
Amino acids, free carnitines and acylcarnitines test system is intended for the measurement and evaluation of amino acid, free carnitine and acylcarnitine concentrations from newborn whole blood filter paper samples. The quantitative analysis of the amino acids, free carnitines and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that…
Other 510(k)s with product code NQL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193103 | NeoBase 2 Non-derivatized MSMS KitNQL · Traditional | Perkinelmer, Inc. | 02/07/2020SE |
| K173568 | NeoBase 2 Non-derivatized MSMS KitNQL · Traditional | Wallac Oy, Subsidiary of Perkinelmer, Inc. | 09/04/2018SE |
| K083130 | Neobase Non-Derivatized MSMS Kit, Model 3040NQL · Traditional | Perkinelmer, Inc. | 07/09/2009SE |
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Questions and answers
When was Neobase Non-Derivatized MSMS Kit Model 3040-001U cleared by the FDA?
Neobase Non-Derivatized MSMS Kit Model 3040-001U (K093916) received a 510(k) decision of Substantially Equivalent on August 23, 2010, 244 days after the submission was received.
What is the product code of K093916?
The FDA product code is NQL – System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry, a Class II (moderate risk) device regulated under 21 CFR 862.1055.