BAYER SPECIAL CHEMISTRY CALIBRATORS— 510(k) K033380
Substantially EquivalentBayer Diagnostics Corp.
FDA 510(k) clearance K033380 for BAYER SPECIAL CHEMISTRY CALIBRATORS, Substantially Equivalent on 2003-12-16. Applicant: Bayer Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Bayer Diagnostics Corp.
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Tarrytown, NY, US
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More clearances from Bayer Diagnostics Corp.
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