MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST— 510(k) K032235
Substantially EquivalentBiosite Incorporated
FDA 510(k) clearance K032235 for MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, Substantially Equivalent on 2004-01-28. Applicant: Biosite Incorporated. Device class: 2.
Clearance details
- Applicant
- Biosite Incorporated
- Product code
- Code NBC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1117
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code NBC
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