TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I— 510(k) K973126
Substantially EquivalentBiosite Incorporated
FDA 510(k) clearance K973126 for TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I, Substantially Equivalent on 1997-10-06. Applicant: Biosite Incorporated. Device class: 2.
Clearance details
- Applicant
- Biosite Incorporated
- Product code
- Code JHX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- 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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