The following data is part of a premarket notification filed by R2 Diagnostics, Inc. with the FDA for Nofact Viii.
| Device ID | K102851 |
| 510k Number | K102851 |
| Device Name: | NOFACT VIII |
| Classification | Plasma, Coagulation Factor Deficient |
| Applicant | R2 DIAGNOSTICS, INC. 1801 COMMERCE DR. South Bend, IN 46628 |
| Contact | Marc D Goldford |
| Correspondent | Marc D Goldford R2 DIAGNOSTICS, INC. 1801 COMMERCE DR. South Bend, IN 46628 |
| Product Code | GJT |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-29 |
| Decision Date | 2011-12-19 |
| Summary: | summary |