Cbc-Cal (TM) Plus/Multiple
FDA 510(k) K862858 · R&D Systems, Inc.
510(k) numberK862858
Submission
- Device name
- Cbc-Cal (TM) Plus/Multiple
- Applicant
- R&D Systems, Inc.
Minneapolis, MN, US - Received
- July 29, 1986
- Decision date
- August 21, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRX – Calibrator For Cell Indices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8150
- Specialty
- Hematology
Other 510(k)s with product code KRX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K160585 | XN CalKRX · Traditional | Streck | 12/22/2016SE |
| K141962 | XN CalKRX · Traditional | Streck | 12/05/2014SE |
| K141955 | XN Cal PFKRX · Traditional | Streck | 12/05/2014SE |
| K120747 | XN Cal PFKRX · Traditional | Streck | 10/22/2012SE |
| K120745 | XN CalKRX · Traditional | Streck | 10/19/2012SE |
| K111204 | Cell-Dyn 22 Plus CalibratorKRX · Traditional | Streck | 12/22/2011SE |
| K083200 | X-CalKRX · Traditional | Streck | 02/03/2009SE |
| K020469 | Cal-Chex CD PlusKRX · Traditional | Streck Laboratories, Inc. | 04/04/2002SE |
| K003991 | Cd-Cal Plus CalibratorKRX · Special | R&D Systems, Inc. | 01/16/2001SE |
| K993375 | CDS LTX Control Latex Particle Suspension and PrimerKRX · Abbreviated | Clinical Diagnostic Solutions, Inc. | 12/20/1999SE |
More from Clinical Diagnostic Solutions, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K160606 | BC-5D Hematology ControlJPK · Traditional | 09/01/2016SE |
| 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 |
Questions and answers
When was Cbc-Cal (TM) Plus/Multiple cleared by the FDA?
Cbc-Cal (TM) Plus/Multiple (K862858) received a 510(k) decision of Substantially Equivalent on August 21, 1986, 23 days after the submission was received.
What is the product code of K862858?
The FDA product code is KRX – Calibrator For Cell Indices, a Class II (moderate risk) device regulated under 21 CFR 864.8150.