Submission Details
| 510(k) Number | K053074 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 01, 2005 |
| Decision Date | March 16, 2006 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
N ANTISERA TO HUMAN CERULOPLASMIN
Mar 2006
Decision
135d
Days
Class 2
Risk
About This 510(k) Submission
K053074 is an FDA 510(k) clearance for the N ANTISERA TO HUMAN CERULOPLASMIN, a Ceruloplasmin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDB), submitted by Dade Behring, Inc. (Newark,, US). The FDA issued a Cleared decision on March 16, 2006, 135 days after receiving the submission on November 1, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5210.
Device Classification
| Product Code | DDB — Ceruloplasmin, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5210 |
Manufacturer
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