THE CARDIAC READER SYSTEM
FDA 510(k) clearance K000784 · decided 2000-05-18
Clearance details
- K-number
- K000784
- Device name
- THE CARDIAC READER SYSTEM
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-03-10
- Decision date
- 2000-05-18
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- MMI
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Great Neck,, NY, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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