The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil D-dimer Hs 500.
| Device ID | K172903 |
| 510k Number | K172903 |
| Device Name: | HemosIL D-Dimer HS 500 |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | Instrumentation Laboratory Co. 180 Hartwell Road Bedford, MA 01730 -4207 |
| Contact | Shajunath Nirupama |
| Correspondent | Shajunath Nirupama Instrumentation Laboratory Co. 180 Hartwell Road Bedford, MA 01730 -4207 |
| Product Code | DAP |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-22 |
| Decision Date | 2017-11-22 |
| Summary: | summary |