COAGUCHEK XS PT CONTROLS
FDA 510(k) clearance K063823 · decided 2007-01-29
Clearance details
- K-number
- K063823
- Device name
- COAGUCHEK XS PT CONTROLS
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-12-26
- Decision date
- 2007-01-29
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- GGN
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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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