Sysmex PDA-410 (Particle Distrib. Analy
FDA 510(k) K822758 · Toa Medical Electronics USA, Inc.
510(k) numberK822758
Submission
- Device name
- Sysmex PDA-410 (Particle Distrib. Analy
- Applicant
- Toa Medical Electronics USA, Inc.
Mchenry, IL, US - Received
- September 14, 1982
- Decision date
- October 18, 1982
- 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 |
|---|---|---|
| K936023 | Sysmex SE-9000 Automated Hematology AnalyzerGKZ · Traditional | 05/02/1994SE |
| K933886 | Toa Medical Electronics CA-5000JPA · Traditional | 01/27/1994SE |
| K931149 | CA-1000 Automated Coagulation AnalyzerJPA · Traditional | 11/03/1993SE |
| K920544 | Sysmex Hematology System AccessoriesGKZ · Traditional | 04/29/1992SE |
| K914744 | Sysmex NE-1500, ModificationGKZ · Traditional | 12/30/1991SE |
| K912494 | Sysmex(Tm) R-3000 Automated Reticulocyte AnalyzerGKL · Traditional | 09/10/1991SE |
| K911173 | Sysmex F-310GKL · Traditional | 07/26/1991SE |
| K911172 | Sysmex F-610GKL · Traditional | 07/26/1991SE |
| K910849 | Sysmex F-810GKL · Traditional | 07/26/1991SE |
| K910745 | Hemoglobin ReagentGKR · Traditional | 07/11/1991SE |
Questions and answers
When was Sysmex PDA-410 (Particle Distrib. Analy cleared by the FDA?
Sysmex PDA-410 (Particle Distrib. Analy (K822758) received a 510(k) decision of Substantially Equivalent on October 18, 1982, 34 days after the submission was received.
What is the product code of K822758?
The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.