ONLINE TDM Vancomycin Gen.3
FDA 510(k) clearance K152245 · decided 2016-01-08
Clearance details
- K-number
- K152245
- Device name
- ONLINE TDM Vancomycin Gen.3
- Applicant
- Roche Diagnostics Operations (Rdo)
- Decision
- Substantially Equivalent
- Date received
- 2015-08-10
- Decision date
- 2016-01-08
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- LEH
- Device class
- 2
- Regulation number
- 862.3950
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.