The following data is part of a premarket notification filed by R2 Diagnostics, Inc. with the FDA for Plasmacon N, Plasmacon L-1, Plasmacon L-2.
| Device ID | K062306 |
| 510k Number | K062306 |
| Device Name: | PLASMACON N, PLASMACON L-1, PLASMACON L-2 |
| Classification | Control, Plasma, Abnormal |
| Applicant | R2 DIAGNOSTICS, INC. 1801 COMMERCE DR. South Bend, IN 46628 |
| Contact | Marc Goldford |
| Correspondent | Marc Goldford R2 DIAGNOSTICS, INC. 1801 COMMERCE DR. South Bend, IN 46628 |
| Product Code | GGC |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-08 |
| Decision Date | 2007-03-16 |
| Summary: | summary |