The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Modification To Standard Human Plasma.
| Device ID | K023141 |
| 510k Number | K023141 |
| Device Name: | MODIFICATION TO STANDARD HUMAN PLASMA |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| 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 | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-20 |
| Decision Date | 2003-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768026812 | K023141 | 000 |
| 00842768018893 | K023141 | 000 |