The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for N Antisera To Human Alpha1-antitrypsin.
| Device ID | K053072 |
| 510k Number | K053072 |
| Device Name: | N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN |
| Classification | Alpha-1-antitrypsin, 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 | DEM |
| CFR Regulation Number | 866.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-01 |
| Decision Date | 2006-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768009938 | K053072 | 000 |
| 00842768009921 | K053072 | 000 |