TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL— 510(k) K974461
Substantially EquivalentBiosite Incorporated
FDA 510(k) clearance K974461 for TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL, Substantially Equivalent on 1997-12-10. Applicant: Biosite Incorporated. Device class: 1.
Clearance details
- Applicant
- Biosite Incorporated
- 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
- San Diego, CA, US
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More clearances from Biosite Incorporated
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