The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Mda D-dimer.
| Device ID | K021877 |
| 510k Number | K021877 |
| Device Name: | MDA D-DIMER |
| Classification | Fibrin Split Products |
| Applicant | BIOMERIEUX, INC. 100 RODOLPHE ST Durham, NC 27712 |
| Contact | Ron Sanyal |
| Correspondent | Ron Sanyal BIOMERIEUX, INC. 100 RODOLPHE ST Durham, NC 27712 |
| Product Code | GHH |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-07 |
| Decision Date | 2002-08-07 |
| Summary: | summary |