The following data is part of a premarket notification filed by Thermo Dma, Inc. with the FDA for Thermo Dma Fructosamine Assay, Model 7500-135/235.
| Device ID | K012525 |
| 510k Number | K012525 |
| Device Name: | THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 |
| Classification | Assay, Glycosylated Hemoglobin |
| 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 | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-06 |
| Decision Date | 2001-10-04 |
| Summary: | summary |