CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM— 510(k) K022329
Substantially EquivalentBayer Diagnostics Corp.
FDA 510(k) clearance K022329 for CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM, Substantially Equivalent on 2002-11-27. Applicant: Bayer Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Bayer Diagnostics Corp.
- Product code
- Code LTK
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code LTK
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