TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS— 510(k) K030088
Substantially EquivalentBiosite Incorporated
FDA 510(k) clearance K030088 for TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS, Substantially Equivalent on 2003-01-17. Applicant: Biosite Incorporated. Device class: 1.
Clearance details
- Applicant
- Biosite Incorporated
- 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
- San Diego, CA, US
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