BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM— 510(k) K033007
Substantially EquivalentBayer Diagnostics Corp.
FDA 510(k) clearance K033007 for BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM, Substantially Equivalent on 2003-11-14. Applicant: Bayer Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Bayer Diagnostics Corp.
- Product code
- Code KXT
- Device class
- Class 2
- Regulation
- 21 CFR 862.3320
- Advisory panel
- Clinical Toxicology
- 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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