RAMP MYOGLOBIN ASSAY— 510(k) K012040
Substantially EquivalentResponse Biomedical Corp.
FDA 510(k) clearance K012040 for RAMP MYOGLOBIN ASSAY, Substantially Equivalent on 2001-12-18. Applicant: Response Biomedical Corp.. Device class: 2.
Clearance details
- Applicant
- Response Biomedical Corp.
- Product code
- Code DDR
- Device class
- Class 2
- Regulation
- 21 CFR 866.5680
- Advisory panel
- Immunology
- 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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