The following data is part of a premarket notification filed by Thermo Dma, Inc. with the FDA for Thermo Trace Ammonia Standards Set, Models Tr-609.
| Device ID | K012878 |
| 510k Number | K012878 |
| Device Name: | THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 |
| Classification | Calibrator, Primary |
| 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 | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-28 |
| Decision Date | 2001-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845275003314 | K012878 | 000 |