Ortho Automated Cell Counter
FDA 510(k) K801545 · Ortho Instruments
510(k) numberK801545
Submission
- Device name
- Ortho Automated Cell Counter
- Applicant
- Ortho Instruments
Walker, MI, US - Received
- July 7, 1980
- Decision date
- September 9, 1980
- 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
Other 510(k)s with product code GKL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K803084 | Ortho Hematology Control Abnormal LowJPK · Traditional | 12/31/1980SE |
| K803083 | Ortho Hemotology Control-NormalJPK · Traditional | 12/31/1980SE |
| K803073 | Ortho Hematology ControlJPK · Traditional | 12/31/1980SE |
| K802094 | Ortho SpectrumGKL · Traditional | 10/10/1980SE |
| K781146 | Hemac Laser Hematology SystemGKL · Traditional | 09/14/1978SE |
Questions and answers
When was Ortho Automated Cell Counter cleared by the FDA?
Ortho Automated Cell Counter (K801545) received a 510(k) decision of Substantially Equivalent on September 9, 1980, 64 days after the submission was received.
What is the product code of K801545?
The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.