ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
FDA 510(k) K170353 · Horiba Abx SAS
510(k) numberK170353
Submission
- Device name
- ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
- Applicant
- Horiba Abx SAS
Montpellier, FR - Received
- February 3, 2017
- Decision date
- November 1, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GKZ – Counter, Differential Cell
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Specialty
- Hematology
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| K251249 | Tru Hematology TestGKZ · Traditional | Truvian Sciences, Inc. | 01/16/2026SE |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ · Traditional | Sysmex America, Inc. | 06/25/2025SE |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ · Traditional | Sysmex America, Inc. | 06/25/2025SE |
| K243283 | Alinity h-series SystemGKZ · Traditional | Abbott Laboratories | 02/20/2025SE |
| K240402 | Cito CBC SystemGKZ · Dual Track | Cytochip, Inc. | 02/03/2025SE |
| K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II…GKZ · Traditional | Beckman Coulter, Inc. | 07/05/2024SE |
| K232946 | Yumizen H2500GKZ · Traditional | Horiba Abx SAS | 05/21/2024SE |
| K240636 | HemoScreen Hematology AnalyzerGKZ · Abbreviated | Pixcell Medical Technologies | 05/02/2024SE |
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| K191993 | Yumizen C1200 CRPDCK · Traditional | 10/03/2019SE |
| K191245 | Yumizen C1200 ALP, Yumizen C1200 AlbuminCJE · Traditional | 08/30/2019SE |
| K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeCJY · Traditional | 07/26/2019SE |
| K151133 | Pentra XLRGKZ · Traditional | 12/09/2015SE |
| K141161 | Abx Micros Es 60 CT; (Open Tube Model), (Close Tube Model)GKZ · Traditional | 12/20/2014SE |
Questions and answers
When was ABX MICROS ES 60 OT and ABX MICROS ES 60 CT cleared by the FDA?
ABX MICROS ES 60 OT and ABX MICROS ES 60 CT (K170353) received a 510(k) decision of Substantially Equivalent on November 1, 2017, 271 days after the submission was received.
What is the product code of K170353?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.