CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL— 510(k) K944247
Substantially EquivalentCala Diagnostics
FDA 510(k) clearance K944247 for CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL, Substantially Equivalent on 1994-10-31. Applicant: Cala Diagnostics. Device class: 1.
Clearance details
- Applicant
- Cala Diagnostics
- Product code
- Code JJT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grover Beach, CA, US
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More clearances from Cala Diagnostics
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