MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST— 510(k) K982679
Substantially EquivalentSpectral Diagnostics, Inc.
FDA 510(k) clearance K982679 for MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST, Substantially Equivalent on 1998-10-07. Applicant: Spectral Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Spectral Diagnostics, Inc.
- 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
- Toronto, Ontario, CA
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More clearances from Spectral Diagnostics, Inc.
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