Technicon H* 3 RTC System (In-Vitro Diagnostic System)
FDA 510(k) K941171 · Miles, Inc.
510(k) numberK941171
Submission
- Device name
- Technicon H* 3 RTC System (In-Vitro Diagnostic System)
- Applicant
- Miles, Inc.
Tarrytown, NY, US - Received
- March 14, 1994
- Decision date
- December 14, 1994
- 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
Other 510(k)s with product code GKZ
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| K253212 | XR-Series (XR-10, XR-20) Automated Hematology AnalyzersGKZ · Traditional | Sysmex America, Inc. | 05/27/2026SE |
| K243348 | Athelas HomeGKZ · Traditional | Athelas, Inc. | 02/06/2026SE |
| 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 |
More from Pixcell Medical Technologies
| 510(k) | Device | Decision |
|---|---|---|
| K950292 | Folate Assay for the Technicon Immuno 1 System, in Vitro Diagnostic SystemCGN · Traditional | 05/02/1995SE |
| K950353 | Technicon Immuno 1(R) System In-Vitro Diagnostic SystemJJE · Traditional | 04/20/1995SE |
| K950186 | Ck-Mb Method for the Technicon Immuno 1(R) System In-Vitro Diagnostic SystemJHW · Traditional | 03/13/1995SE |
| K945655 | Creatinine (Enzymatic UV) Procedure for Technicon Systems (in Vitro Diagnostic Test…CGX · Traditional | 01/05/1995SE |
| K943376 | Opera SystemJJC · Traditional | 09/14/1994SE |
| K941156 | Technison Axon SystemKHS · Traditional | 04/26/1994SE |
| K933682 | Direct Amylase (Ec 3.2.1.1) Method for Technicon SystemsJFJ · Traditional | 04/12/1994SE |
| K935287 | Iron -Ii (Fe-Ii) Method/Tech Chem 1(R) 1+TM SystemJIY · Traditional | 01/03/1994SE |
| K933478 | Technicon H*1 Systems, Labfacts Software for U.I.W. Versions 4.11 & 5.11GKZ · Traditional | 11/22/1993SE |
| K933475 | Technicon H* 2 System, Labfacts Software for U.I.W. Versions 4.11 & 5.11GKZ · Traditional | 11/22/1993SE |
Questions and answers
When was Technicon H* 3 RTC System (In-Vitro Diagnostic System) cleared by the FDA?
Technicon H* 3 RTC System (In-Vitro Diagnostic System) (K941171) received a 510(k) decision of Substantially Equivalent on December 14, 1994, 275 days after the submission was received.
What is the product code of K941171?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.