Submission Details
| 510(k) Number | K053072 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 01, 2005 |
| Decision Date | March 28, 2006 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN
Mar 2006
Decision
147d
Days
Class 2
Risk
About This 510(k) Submission
K053072 is an FDA 510(k) clearance for the N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN, a Alpha-1-antitrypsin, Antigen, Antiserum, Control (Class II — Special Controls, product code DEM), submitted by Dade Behring, Inc. (Newark,, US). The FDA issued a Cleared decision on March 28, 2006, 147 days after receiving the submission on November 1, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5130.
Device Classification
| Product Code | DEM — Alpha-1-antitrypsin, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5130 |
Manufacturer
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