COAGUCHEK XS PT CONTROLS— 510(k) K063823
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K063823 for COAGUCHEK XS PT CONTROLS, Substantially Equivalent on 2007-01-29. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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More clearances from Roche Diagnostics Corp.
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