FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
STA R Max 3, STA Compact Max 3
K Number: K212183
·
Decision Jun 7, 2023
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
3
Review Days
694
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Basic Information
- Device Name
- STA R Max 3, STA Compact Max 3
- K Number
- K212183
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diagnostica Stago S.A.S
- Date Received
- July 13, 2021
- Decision Date
- June 7, 2023
- Product Code
- JPA
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | FDA class 2 | Hematology |
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