The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Control Plasma N, Proc Control Plasma.
| Device ID | K042333 |
| 510k Number | K042333 |
| Device Name: | CONTROL PLASMA N, PROC CONTROL PLASMA |
| Classification | Plasma, Coagulation Control |
| Applicant | DADE BEHRING, INC. 500 GBC DR. Newark, DE 19702 |
| Contact | Radames Riesgo |
| Correspondent | Radames Riesgo DADE BEHRING, INC. 500 GBC DR. Newark, DE 19702 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-30 |
| Decision Date | 2004-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768009174 | K042333 | 000 |
| 00842768007774 | K042333 | 000 |
| 00842768018909 | K042333 | 000 |
| 00842768019005 | K042333 | 000 |