Ortho Hematology Control Abnormal Low
FDA 510(k) K803084 · Ortho Instruments
510(k) numberK803084
Submission
- Device name
- Ortho Hematology Control Abnormal Low
- Applicant
- Ortho Instruments
Mchenry, IL, US - Received
- December 5, 1980
- Decision date
- December 31, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JPK – Mixture, Hematology Quality Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
Other 510(k)s with product code JPK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K160590 | XN CheckJPK · Traditional | Streck | 12/22/2016SE |
| K160588 | XN Check BFJPK · Traditional | Streck | 12/22/2016SE |
| K160586 | Xn-L CheckJPK · Traditional | Streck | 12/22/2016SE |
| K160606 | BC-5D Hematology ControlJPK · Traditional | R&D Systems, Inc. | 09/01/2016SE |
| K141964 | XN CheckJPK · Traditional | Streck | 12/05/2014SE |
| K141957 | XN Check BFJPK · Traditional | Streck | 12/05/2014SE |
| K130962 | R&D 5D Retic Hematology ControlJPK · Special | R&D Systems, Inc. | 07/24/2013SE |
| K120744 | XN Check BFJPK · Traditional | Streck | 10/19/2012SE |
| K120742 | XN CheckJPK · Traditional | Streck | 10/19/2012SE |
| K101578 | R&D Systems Body Fluid-I Hematology ControlJPK · Traditional | R&D Systems, Inc. | 04/28/2011SE |
More from R&D Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K803083 | Ortho Hemotology Control-NormalJPK · Traditional | 12/31/1980SE |
| K803073 | Ortho Hematology ControlJPK · Traditional | 12/31/1980SE |
| K802094 | Ortho SpectrumGKL · Traditional | 10/10/1980SE |
| K801545 | Ortho Automated Cell CounterGKL · Traditional | 09/09/1980SE |
| K781146 | Hemac Laser Hematology SystemGKL · Traditional | 09/14/1978SE |
Questions and answers
When was Ortho Hematology Control Abnormal Low cleared by the FDA?
Ortho Hematology Control Abnormal Low (K803084) received a 510(k) decision of Substantially Equivalent on December 31, 1980, 26 days after the submission was received.
What is the product code of K803084?
The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.