Coulter Mean Platelet Volume Calibrator
FDA 510(k) K843910 · Coulter Electronics, Inc.
510(k) numberK843910
Submission
- Device name
- Coulter Mean Platelet Volume Calibrator
- Applicant
- Coulter Electronics, Inc.
Hialeah, FL, US - Received
- October 3, 1984
- Decision date
- January 7, 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 |
| K852016 | Laser Plateletcal/MultipleKRY · Traditional | R&D Systems, Inc. | 07/09/1985SE |
| 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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| K921567 | Coulter MH017GKZ · Traditional | 07/06/1992SE |
| K912133 | PX Coulter(R) Cell ControlJPK · Traditional | 07/17/1991SE |
| K911385 | Coulter(R) MH010GKZ · Traditional | 06/17/1991SE |
| K905771 | Coulter Dart Ast (Got) ReagentCIT · Traditional | 02/26/1991SE |
Questions and answers
When was Coulter Mean Platelet Volume Calibrator cleared by the FDA?
Coulter Mean Platelet Volume Calibrator (K843910) received a 510(k) decision of Substantially Equivalent on January 7, 1985, 96 days after the submission was received.
What is the product code of K843910?
The FDA product code is KRY – Calibrator For Platelet Counting, a Class II (moderate risk) device regulated under 21 CFR 864.8175.