Laser Plateletcal/Multiple
FDA 510(k) K852016 · R&D Systems, Inc.
510(k) numberK852016
Submission
- Device name
- Laser Plateletcal/Multiple
- Applicant
- R&D Systems, Inc.
Minneapolis, MN, US - Received
- May 9, 1985
- Decision date
- July 9, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRY – Calibrator For Platelet Counting
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8175
- Specialty
- Hematology
Other 510(k)s with product code KRY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K862122 | S-Cal Hematology CalibratorKRY · Traditional | Coulter Electronics, Inc. | 05/20/1987SE |
| K843910 | Coulter Mean Platelet Volume CalibratorKRY · Traditional | Coulter Electronics, Inc. | 01/07/1985SE |
| K840794 | S-Cal Hematology CalibratorKRY · Traditional | Coulter Electronics, Inc. | 04/04/1984SE |
| K821851 | Control Diagnostics Platelet ControlKRY · Traditional | Immunogenetics | 09/02/1982SE |
| K781601 | Tekni-CalKRY · Traditional | Streck Laboratories, Inc. | 10/10/1978SE |
| K781133 | Pc-CalibratorKRY · Traditional | Streck Laboratories, Inc. | 08/14/1978SE |
| K770143 | TQC Calibration Reference for PlateletsKRY · Traditional | Technicon Instruments Corp. | 01/30/1978SE |
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| 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 Laser Plateletcal/Multiple cleared by the FDA?
Laser Plateletcal/Multiple (K852016) received a 510(k) decision of Substantially Equivalent on July 9, 1985, 61 days after the submission was received.
What is the product code of K852016?
The FDA product code is KRY – Calibrator For Platelet Counting, a Class II (moderate risk) device regulated under 21 CFR 864.8175.