CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)— 510(k) K981474
Substantially EquivalentSpectral Diagnostics, Inc.
FDA 510(k) clearance K981474 for CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I), Substantially Equivalent on 1998-05-07. Applicant: Spectral Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Spectral Diagnostics, Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Toronto, Ontario, CA
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