TQC Calibration Reference for Platelets
FDA 510(k) K770143 · Technicon Instruments Corp.
510(k) numberK770143
Submission
- Device name
- TQC Calibration Reference for Platelets
- Applicant
- Technicon Instruments Corp.
Mchenry, IL, US - Received
- January 24, 1977
- Decision date
- January 30, 1978
- 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 |
| 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 |
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Questions and answers
When was TQC Calibration Reference for Platelets cleared by the FDA?
TQC Calibration Reference for Platelets (K770143) received a 510(k) decision of Substantially Equivalent on January 30, 1978, 371 days after the submission was received.
What is the product code of K770143?
The FDA product code is KRY – Calibrator For Platelet Counting, a Class II (moderate risk) device regulated under 21 CFR 864.8175.