Tina-quant Transferrin ver.2 (urine application)— 510(k) K182095
Substantially EquivalentRoche Diagnostics Operations (Rdo)
FDA 510(k) clearance K182095 for Tina-quant Transferrin ver.2 (urine application), Substantially Equivalent on 2018-11-05. Applicant: Roche Diagnostics Operations (Rdo). Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Operations (Rdo)
- Product code
- Code DDG
- Device class
- Class 2
- Regulation
- 21 CFR 866.5880
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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