The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Mda B.30.
| Device ID | K050513 |
| 510k Number | K050513 |
| Device Name: | MDA B.30 |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | BIOMERIEUX, INC. 100 RODOLPHE ST Durham, NC 27712 |
| Contact | Jocelyn Jennings |
| Correspondent | Jocelyn Jennings BIOMERIEUX, INC. 100 RODOLPHE ST Durham, NC 27712 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-01 |
| Decision Date | 2005-04-01 |
| Summary: | summary |