The following data is part of a De Novo classification by Perkinelmer Life Sciences, Inc. with the FDA for Neogram Amino Acids And Acylcarnitines Tandem Mass Spectrometry Kit, Model Ms-8970.
DeNovo ID | DEN040002 |
Device Name: | NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970 |
Classification | System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry |
Applicant | PERKINELMER LIFE SCIENCES, INC. 3985 Eastern Road Norton, OH 44203 |
Contact | Cindy Lloyd |
Product Code | NQL |
CFR Regulation Number | 862.1055 [🔎] |
Decision | Granted (DENG) |
510(k) Premarket Notification | K031878 |
Review Advisory Board | Clinical Chemistry |
Classification Advisory | Clinical Chemistry |
Type | Post-NSE |
Date Received | 2004-07-02 |
Decision Date | 2004-08-24 |
Reclassification Order: | Reclassification Order |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06438147283842 | DEN040002 | 000 |
06438147283835 | DEN040002 | 000 |