The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for N Antisera To Human Complement Factors (c3c, C4).
| Device ID | K050665 |
| 510k Number | K050665 |
| Device Name: | N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) |
| Classification | Complement C3, Antigen, Antiserum, Control |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG. 500 M.S. 514; POX 6101 Newark, DE 19714 -6101 |
| Contact | Donna A Wolf |
| Correspondent | Donna A Wolf DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG. 500 M.S. 514; POX 6101 Newark, DE 19714 -6101 |
| Product Code | CZW |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-15 |
| Decision Date | 2005-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768009723 | K050665 | 000 |
| 00842768009716 | K050665 | 000 |
| 00842768009709 | K050665 | 000 |
| 00842768009693 | K050665 | 000 |