510(k) DEN040002
DEN040002 is an FDA 510(k) premarket notification submitted by Perkinelmer Life Sciences, Inc. for the device "NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970". The FDA issued a decision of De Novo Granted on August 24, 2004. 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 Life Sciences, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 24, 2004
- Date Received
- July 2, 2004
- Clearance Type
- Post-NSE
- 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.