FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
K Number: K031038
·
Decision Jun 23, 2003
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
44
Applicant Total
46
Review Days
83
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Basic Information
- Device Name
- ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
- K Number
- K031038
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1117
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Healthcare, LLC
- Date Received
- April 1, 2003
- Decision Date
- June 23, 2003
- 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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