MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
FDA 510(k) clearance K032235 · decided 2004-01-28
Clearance details
- K-number
- K032235
- Device name
- MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
- Applicant
- Biosite Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2003-07-21
- Decision date
- 2004-01-28
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- NBC
- Device class
- 2
- Regulation number
- 862.1117
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.