FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000
K Number: K010266
·
Decision Mar 16, 2001
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
44
Applicant Total
46
Review Days
46
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Basic Information
- Device Name
- TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000
- K Number
- K010266
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1117
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biosite Incorporated
- Date Received
- January 29, 2001
- Decision Date
- March 16, 2001
- Product Code
- NBC
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NBC | Test, Natriuretic Peptide | FDA class 2 | Clinical Chemistry |
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