FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABBOTT AXSYM TROPONIN-I ADV
K Number: K041811
·
Decision Sep 10, 2004
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
91
Applicant Total
857
Review Days
66
Basic Information
- Device Name
- ABBOTT AXSYM TROPONIN-I ADV
- K Number
- K041811
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ABBOTT LABORATORIES
- Date Received
- July 6, 2004
- Decision Date
- September 10, 2004
- Product Code
- MMI
- 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 |
|---|---|---|---|
| MMI | Immunoassay Method, Troponin Subunit | FDA class 2 | Clinical Chemistry |
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