FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
K Number: K160276
·
Decision Mar 3, 2016
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
48
Applicant Total
321
Review Days
30
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Basic Information
- Device Name
- ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
- K Number
- K160276
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.5400
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumentation Laboratory CO
- Date Received
- February 2, 2016
- Decision Date
- March 3, 2016
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GKP), ordered by most recent decision date.
ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP Family 70 Series
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP 700 LAS
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Instrumentation Laboratory CO
| K Number | Device Name | ||
|---|---|---|---|
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM | Sep 29, 2023 | Substantially Equivalent |
| K223187 | HemosIL Liquid Anti-Xa | Jun 23, 2023 | Substantially Equivalent |
| K223090 | GEM Premier ChemSTAT | Jan 27, 2023 | Substantially Equivalent |
| K223402 | HemosIL von Willebrand Factor Antigen | Dec 9, 2022 | Substantially Equivalent |
| K213464 | HemosIL Liquid Anti-Xa | Oct 4, 2022 | Substantially Equivalent |
| K213426 | HemosIL ReadiPlasTin | Aug 16, 2022 | Substantially Equivalent |
| K203790 | GEM Premier 5000 | Aug 20, 2021 | Substantially Equivalent |
| DEN190032 | HemosIL Liquid Anti-Xa | Sep 17, 2020 | Unknown |
| K200033 | HemosIL von Willebrand Factor Antigen | Aug 19, 2020 | Substantially Equivalent |
| K183549 | GEM Premier ChemSTAT | Feb 16, 2019 | Substantially Equivalent |