The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Protein S Ac.
| Device ID | K022290 |
| 510k Number | K022290 |
| Device Name: | PROTEIN S AC |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| 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 | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-15 |
| Decision Date | 2002-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768006678 | K022290 | 000 |
| 00630414640457 | K022290 | 000 |