Tech-Cal(Tm)/Multiple
FDA 510(k) K881161 · R&D Systems, Inc.
510(k) numberK881161
Submission
- Device name
- Tech-Cal(Tm)/Multiple
- Applicant
- R&D Systems, Inc.
Minneapolis, MN, US - Received
- March 18, 1988
- Decision date
- May 2, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KSA – Calibrator For Red-Cell And White-Cell Counting
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8185
- Specialty
- Hematology
Other 510(k)s with product code KSA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K943268 | SCS-1000 (Sysmex Calibrator System)KSA · Traditional | Streck Laboratories, Inc. | 12/15/1994SE |
| K897060 | Cbc-Cal(Tm) Plus Hematology Calibrator/MultipleKSA · Traditional | R&D Systems, Inc. | 01/02/1990SE |
| K864664 | H-1 Setpoint Platelet and Rbc/Wbc CalibratorsKSA · Traditional | Technicon Instruments Corp. | 02/06/1987SE |
| K854823 | Cbc-Cal/MultipleKSA · Traditional | R&D Systems, Inc. | 02/13/1986SE |
| K844708 | Tri-Count CalibratorKSA · Traditional | Hematology Marketing Assoc. | 03/05/1985SE |
| K813530 | Hemotology CalibratorKSA · Traditional | American Dade | 02/22/1982SE |
| K813375 | Hematology Calibrator S-CalKSA · Traditional | Coulter Electronics, Inc. | 02/04/1982SE |
More from Coulter Electronics, 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 Tech-Cal(Tm)/Multiple cleared by the FDA?
Tech-Cal(Tm)/Multiple (K881161) received a 510(k) decision of Substantially Equivalent on May 2, 1988, 45 days after the submission was received.
What is the product code of K881161?
The FDA product code is KSA – Calibrator For Red-Cell And White-Cell Counting, a Class II (moderate risk) device regulated under 21 CFR 864.8185.