FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACL TOP Family 70 Series
K Number: K231031
·
Decision Jun 21, 2023
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
48
Applicant Total
3
Review Days
71
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Basic Information
- Device Name
- ACL TOP Family 70 Series
- K Number
- K231031
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5400
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumentation Laboratory Company
- Date Received
- April 11, 2023
- Decision Date
- June 21, 2023
- Product Code
- GKP
- 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 |
|---|---|---|---|
| GKP | Instrument, Coagulation, Automated | FDA class 2 | Hematology |
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