RAMP CK-MB ASSAY— 510(k) K033747
Substantially EquivalentResponse Biomedical Corp.
FDA 510(k) clearance K033747 for RAMP CK-MB ASSAY, Substantially Equivalent on 2004-05-17. Applicant: Response Biomedical Corp.. Device class: 2.
Clearance details
- Applicant
- Response Biomedical Corp.
- Product code
- Code JHX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burnaby, British Columbia, CA
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More clearances from Response Biomedical Corp.
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