ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID
FDA 510(k) clearance K110446 · decided 2011-05-03
Clearance details
- K-number
- K110446
- Device name
- ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2011-02-16
- Decision date
- 2011-05-03
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- DKZ
- Device class
- 2
- Regulation number
- 862.3100
- 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.
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