FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Access hsTnI
K Number: K243483
·
Decision Aug 1, 2025
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
94
Applicant Total
270
Review Days
266
Basic Information
- Device Name
- Access hsTnI
- K Number
- K243483
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beckman Coulter, Inc.
- Date Received
- November 8, 2024
- Decision Date
- August 1, 2025
- 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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