FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Alinity i STAT High Sensitivity Troponin-I
K Number: K202525
·
Decision May 19, 2022
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
94
Applicant Total
4
Review Days
625
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Basic Information
- Device Name
- Alinity i STAT High Sensitivity Troponin-I
- K Number
- K202525
- 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 Diagnostics Division
- Date Received
- September 1, 2020
- Decision Date
- May 19, 2022
- 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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