CERULOPLASMIN, MODEL 2055953— 510(k) K062114
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K062114 for CERULOPLASMIN, MODEL 2055953, Substantially Equivalent on 2007-01-31. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code CHN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5210
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code CHN
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