Carbamazepine Gen 4— 510(k) K151578
Substantially EquivalentRoche Diagnostics Operations (Rdo)
FDA 510(k) clearance K151578 for Carbamazepine Gen 4, Substantially Equivalent on 2015-10-22. Applicant: Roche Diagnostics Operations (Rdo). Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Operations (Rdo)
- Product code
- Code KLT
- Device class
- Class 2
- Regulation
- 21 CFR 862.3645
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code KLT
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