Control Diagnostics Platelet Control
FDA 510(k) K821851 · Immunogenetics
510(k) numberK821851
Submission
- Device name
- Control Diagnostics Platelet Control
- Applicant
- Immunogenetics
Mchenry, IL, US - Received
- June 23, 1982
- Decision date
- September 2, 1982
- 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 |
| 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 |
| 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 |
Questions and answers
When was Control Diagnostics Platelet Control cleared by the FDA?
Control Diagnostics Platelet Control (K821851) received a 510(k) decision of Substantially Equivalent on September 2, 1982, 71 days after the submission was received.
What is the product code of K821851?
The FDA product code is KRY – Calibrator For Platelet Counting, a Class II (moderate risk) device regulated under 21 CFR 864.8175.