N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN— 510(k) K053072
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K053072 for N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN, Substantially Equivalent on 2006-03-28. Applicant: Dade Behring, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code DEM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5130
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Recent devices under product code DEM
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- K050596 — QUANTIA A1-AT
- K031857 — ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
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