The following data is part of a premarket notification filed by Perkinelmer, Inc. with the FDA for Neobase Non-derivatized Msms Kit Model 3040-001u.
| Device ID | K093916 |
| 510k Number | K093916 |
| Device Name: | NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U |
| Classification | System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry |
| Applicant | PERKINELMER, INC. 8275 CARLOWAY ROAD Indianapolis, IN 46236 |
| Contact | Kay Taylor |
| Correspondent | Kay Taylor PERKINELMER, INC. 8275 CARLOWAY ROAD Indianapolis, IN 46236 |
| Product Code | NQL |
| CFR Regulation Number | 862.1055 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-22 |
| Decision Date | 2010-08-23 |
| Summary: | summary |