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 |