FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
STA- NeoPTimal
K Number: K211485
·
Decision Dec 23, 2022
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
126
Applicant Total
3
Review Days
589
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STA- NeoPTimal
- K Number
- K211485
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7750
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diagnostica Stago S.A.S
- Date Received
- May 13, 2021
- Decision Date
- December 23, 2022
- Product Code
- GJS
- 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 |
|---|---|---|---|
| GJS | Test, Time, Prothrombin | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GJS), ordered by most recent decision date.
CoaguChek XS Plus System
FDA 510(k)
FDA Class 2
·Hematology
microINR System
FDA 510(k)
FDA Class 2
·Hematology
microINR System
FDA 510(k)
FDA Class 2
·Hematology
Xprecia Prime Coagulation System
FDA 510(k)
FDA Class 2
·Hematology
i-STAT PTplus Cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Hematology
microINR System
FDA 510(k)
FDA Class 2
·Hematology