510(k) K093916
K093916 is an FDA 510(k) premarket notification submitted by Perkinelmer, Inc. for the device "NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U". The FDA issued a decision of Substantially Equivalent on August 23, 2010. The device falls under product code NQL (System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry), a Class II device regulated under 21 CFR 862.1055. Perkinelmer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 2010
- Date Received
- December 22, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
- Device Class
- Class II
- Regulation Number
- 862.1055
- Review Panel
- CH
- Submission Type
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 should aid in identifying elevated levels of these metabolites for screening newborns for one or more of several metabolic disorders.