The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Control Plasma N.
| Device ID | K001256 |
| 510k Number | K001256 |
| Device Name: | CONTROL PLASMA N |
| Classification | Plasma, Control, Normal |
| Applicant | DADE BEHRING, INC. PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Donna A Wolf |
| Correspondent | Donna A Wolf DADE BEHRING, INC. PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | GIZ |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-19 |
| Decision Date | 2000-05-24 |