PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS— 510(k) K033306
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K033306 for PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS, Substantially Equivalent on 2003-12-15. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code DKB
- Device class
- Class 2
- Regulation
- 21 CFR 862.3200
- 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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