FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
K Number: DEN000010
·
Decision Nov 20, 2000
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
44
Applicant Total
46
Review Days
5
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Basic Information
- Device Name
- TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
- K Number
- DEN000010
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 862.1117
- Medical Specialty
- Clinical Chemistry
- Decision
- Unknown
- Applicant
- Biosite Incorporated
- Date Received
- November 15, 2000
- Decision Date
- November 20, 2000
- 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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Other Clearances by Biosite Incorporated
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| K060788 | TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 | Jul 10, 2006 | Substantially Equivalent |
| K060791 | TRIAGE TOX DRUG SCREEN, MODEL 94400 | Jun 22, 2006 | Substantially Equivalent |
| K052789 | TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 | Jan 23, 2006 | Substantially Equivalent |