Analyzer, Model CC-720
FDA 510(k) K790026 · Sysmex Corp.
510(k) numberK790026
Submission
- Device name
- Analyzer, Model CC-720
- Applicant
- Sysmex Corp.
Mchenry, IL, US - Received
- January 3, 1979
- Decision date
- February 8, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GKL – Counter, Cell, Automated (Particle Counter)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5200
- Specialty
- Hematology
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|---|---|---|---|
| K152776 | Glocyte Automated Cell Counter SystemGKL · Traditional | Advanced Instruments, Inc. | 05/27/2016SE |
| K091539 | Iq 200 Urine Analizer Body Fluids ModuleGKL · Traditional | Iris Diagnostics | 08/31/2010SE |
| K071652 | Hemocue WBC SystemGKL · Traditional | Hemocue AB | 10/25/2007SE |
| K051693 | Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide SystemGKL · Traditional | Bayer Healthcare, LLC | 12/07/2005SE |
| K050235 | Iq 200 Urine Analyzer Body Fluids ModuleGKL · Traditional | Iris International, Inc. | 03/23/2005SE |
| K032677 | Sysmex POCH-100IGKL · Traditional | Sysmex America, Inc. | 02/11/2004SE |
| K022331 | Advia 120 Hematology System, Cerebrospinal Fluid MethodGKL · Special | Bayer Diagnostics Corp. | 09/11/2002SE |
| K001683 | Sysmex R-500GKL · Traditional | Sysmex Corporation of America | 08/21/2000SE |
| K991070 | Coulter Z2 AnalyzerGKL · Traditional | Coulter Corp. | 05/11/1999SE |
| K981950 | Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500GKL · Traditional | Sysmex Corp. | 11/03/1998SE |
More from Sysmex Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K012372 | Sysmex UF-50LKM · Traditional | 09/28/2001SE |
| K992875 | Sysmex XE-2100, Automatated Hematology AnalyzerGKZ · Traditional | 11/09/1999SE |
| K981950 | Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500GKL · Traditional | 11/03/1998SE |
| K981761 | Sysmex KX-21, Automated Hematology AnalyzerGKL · Traditional | 08/14/1998SE |
| K971736 | Sysmex Immature Reticulocyte Fraction (Irf) ParameterGKZ · Traditional | 08/26/1997SE |
| K964946 | Sysmex CA-1000/SYSMEX CA-5000JPA · Traditional | 03/18/1997SE |
| K964375 | Sysmex SE/RAM-1GKL · Traditional | 03/13/1997SE |
| K961054 | Sysmex UF-100LKM · Traditional | 10/28/1996SE |
| K950508 | Sysmex SF-3000FPK · Traditional | 11/03/1995SE |
| K945837 | Sysmex(Tm) F-820, 520GKZ · Traditional | 06/09/1995SE |
Questions and answers
When was Analyzer, Model CC-720 cleared by the FDA?
Analyzer, Model CC-720 (K790026) received a 510(k) decision of Substantially Equivalent on February 8, 1979, 36 days after the submission was received.
What is the product code of K790026?
The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.