RAMP CK-MB ASSAY
FDA 510(k) clearance K033747 · decided 2004-05-17
Clearance details
- K-number
- K033747
- Device name
- RAMP CK-MB ASSAY
- Applicant
- Response Biomedical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-01
- Decision date
- 2004-05-17
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- JHX
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Burnaby, British Columbia, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.