The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil D-dimer Hs.
| Device ID | K151534 |
| 510k Number | K151534 |
| Device Name: | HemosIL D-Dimer HS |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL Road Bedford, MA 01730 |
| Contact | Nikita Malladi |
| Correspondent | Nikita Malladi INSTRUMENTATION LABORATORY CO. 180 HARTWELL Road Bedford, MA 01730 |
| Product Code | DAP |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-08 |
| Decision Date | 2015-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950358695 | K151534 | 000 |