The following data is part of a premarket notification filed by Thermo Dma, Inc. with the FDA for Thermo Dma Data-cal Calibrator, Model 1905-050.
| Device ID | K022108 |
| 510k Number | K022108 |
| Device Name: | THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | THERMO DMA, INC. 845 AVE. G EAST Arlington, TX 76011 |
| Contact | Thomas Dollar |
| Correspondent | Thomas Dollar THERMO DMA, INC. 845 AVE. G EAST Arlington, TX 76011 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-28 |
| Decision Date | 2002-07-25 |
| Summary: | summary |