CRP HS TEST SYSTEM
FDA 510(k) clearance K003400 · decided 2001-05-10
Clearance details
- K-number
- K003400
- Device name
- CRP HS TEST SYSTEM
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-11-01
- Decision date
- 2001-05-10
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- DCN
- Device class
- 2
- Regulation number
- 866.5270
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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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