The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Control Plasma N.
| Device ID | K023309 |
| 510k Number | K023309 |
| Device Name: | CONTROL PLASMA N |
| Classification | Plasma, Control, Normal |
| Applicant | DADE BEHRING, INC. 514 GBC DR. Newark, DE 19702 |
| Contact | Donna A Wolf |
| Correspondent | Donna A Wolf DADE BEHRING, INC. 514 GBC DR. Newark, DE 19702 |
| Product Code | GIZ |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-03 |
| Decision Date | 2002-11-01 |
| Summary: | summary |