ATAC CALCIUM REAGENT AND ATAC CALIBRATOR— 510(k) K023105
Substantially EquivalentElan Diagnostics
FDA 510(k) clearance K023105 for ATAC CALCIUM REAGENT AND ATAC CALIBRATOR, Substantially Equivalent on 2003-03-13. Applicant: Elan Diagnostics. Device class: 2.
Clearance details
- Applicant
- Elan Diagnostics
- Product code
- Code CIC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1145
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
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More clearances from Elan Diagnostics
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