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 |