BC-5D Hematology Control
FDA 510(k) K160606 · R&D Systems, Inc.
510(k) numberK160606
Submission
- Device name
- BC-5D Hematology Control
- Applicant
- R&D Systems, Inc.
Minneapolis, MN, US - Received
- March 2, 2016
- Decision date
- September 1, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K100790 | Coulter Lin-X Linearity Control, Model A81196JPK · Traditional | Beckman Coulter, Inc. | 12/21/2010SE |
More from Beckman Coulter, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K130962 | R&D 5D Retic Hematology ControlJPK · Special | 07/24/2013SE |
| K101578 | R&D Systems Body Fluid-I Hematology ControlJPK · Traditional | 04/28/2011SE |
| K100050 | R & D Systems Xeret Hematology ControlJPK · Special | 01/29/2010SE |
| K091433 | R&D Systems Tetic-I Plus Hemotology ControlJPK · Special | 10/28/2009SE |
| K073178 | HCT Extended Hematology Control, Model HCT004JPK · Traditional | 12/27/2007SE |
| K072846 | CSF Automated Control, Models CSF001, CSF003JPK · Traditional | 11/26/2007SE |
| K072268 | HC WBC Hematology Control, Model: WBC00SJPK · Traditional | 11/20/2007SE |
| K072096 | CBC-5D Plus Retics Hematology Control, Models: 5DR03, 5DR04JPK · Special | 08/20/2007SE |
| K070334 | R&D Sickle QC ControlGGM · Traditional | 03/29/2007SE |
| K061511 | R&D CBC-3D + CRP Hematology ControlJPK · Special | 07/10/2006SE |
Questions and answers
When was BC-5D Hematology Control cleared by the FDA?
BC-5D Hematology Control (K160606) received a 510(k) decision of Substantially Equivalent on September 1, 2016, 183 days after the submission was received.
What is the product code of K160606?
The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.