ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY— 510(k) K031857
Substantially EquivalentBayer Diagnostics Corp.
FDA 510(k) clearance K031857 for ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY, Substantially Equivalent on 2003-09-04. Applicant: Bayer Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Bayer Diagnostics Corp.
- 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
- Tarrytown, NY, US
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More clearances from Bayer Diagnostics Corp.
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