FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
K Number: K170353
·
Decision Nov 1, 2017
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
17
Review Days
271
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
- ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
- K Number
- K170353
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HORIBA ABX SAS
- Date Received
- February 3, 2017
- Decision Date
- November 1, 2017
- Product Code
- GKZ
- 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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GKZ), ordered by most recent decision date.
XR-Series (XR-10, XR-20) Automated Hematology Analyzers
FDA 510(k)
FDA Class 2
·Hematology
Athelas Home
FDA 510(k)
FDA Class 2
·Hematology
Tru Hematology Test
FDA 510(k)
FDA Class 2
·Hematology
Sysmex XR-Series (XR-10) Automated Hematology Analyzer
FDA 510(k)
FDA Class 2
·Hematology
Sysmex XR-Series (XR-20) Automated Hematology Analyzer
FDA 510(k)
FDA Class 2
·Hematology
Alinity h-series System
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by HORIBA ABX SAS
| K Number | Device Name | ||
|---|---|---|---|
| K232946 | Yumizen H2500 | May 21, 2024 | Substantially Equivalent |
| K193649 | Yumizen C1200 Creatinine PAP | May 10, 2021 | Substantially Equivalent |
| K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M | Jun 26, 2020 | Substantially Equivalent |
| K192028 | Yumizen C1200 CRP | Jun 25, 2020 | Substantially Equivalent |
| K191562 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor | Mar 6, 2020 | Substantially Equivalent |
| K191993 | Yumizen C1200 CRP | Oct 3, 2019 | Substantially Equivalent |
| K191245 | Yumizen C1200 ALP, Yumizen C1200 Albumin | Aug 30, 2019 | Substantially Equivalent |
| K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | Jul 26, 2019 | Substantially Equivalent |
| K151133 | PENTRA XLR | Dec 9, 2015 | Substantially Equivalent |
| K141161 | ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL) | Dec 20, 2014 | Substantially Equivalent |