The following data is part of a premarket notification filed by Perkinelmer, Inc. with the FDA for Neobase Non-derivatized Msms Kit, Model 3040.
| Device ID | K083130 |
| 510k Number | K083130 |
| Device Name: | NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 |
| Classification | System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry |
| Applicant | PERKINELMER, INC. 8275 CARLOWAY ROAD Indianapolis, IN 46236 |
| Contact | Kay A Taylor |
| Correspondent | Kay A 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 | 2008-10-23 |
| Decision Date | 2009-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438147311859 | K083130 | 000 |
| 06438147295708 | K083130 | 000 |
| 06438147295692 | K083130 | 000 |