CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500— 510(k) K080183
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K080183 for CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500, Substantially Equivalent on 2008-03-25. Applicant: Roche Diagnostics Corp.. Device class: 1.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code DIF
- Device class
- Class 1
- Regulation
- 21 CFR 862.3280
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Indianapolis, IN, US
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More clearances from Roche Diagnostics Corp.
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