The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for N Antisera To Human Ceruloplasmin.
| Device ID | K053074 |
| 510k Number | K053074 |
| Device Name: | N ANTISERA TO HUMAN CERULOPLASMIN |
| Classification | Ceruloplasmin, Antigen, Antiserum, Control |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714 |
| Contact | Kathleen A Dray-lyons |
| Correspondent | Kathleen A Dray-lyons DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714 |
| Product Code | DDB |
| CFR Regulation Number | 866.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-01 |
| Decision Date | 2006-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768011382 | K053074 | 000 |