TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS— 510(k) K030089
Substantially EquivalentBiosite Incorporated
FDA 510(k) clearance K030089 for TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS, Substantially Equivalent on 2003-01-23. 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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