Calibrator For Platelet Counting
This device is a calibrator used to standardize automated hematology analyzers for platelet counting, ensuring accurate quantification of platelets in blood samples used for the assessment of bleeding disorders and treatment monitoring. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KRY, regulated under 21 CFR 864.8175 within the Hematology specialty. No special flags apply.
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Basic Information
- Product Code
- KRY
- Device Class
- FDA class 2
- Regulation Number
- 864.8175
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K862122 | S-CAL HEMATOLOGY CALIBRATOR | May 20, 1987 | Substantially Equivalent | Coulter Electronics, Inc. |
| K852016 | LASER PLATELETCAL/MULTIPLE | Jul 09, 1985 | Substantially Equivalent | R&D Systems, Inc. |
| K843910 | COULTER MEAN PLATELET VOLUME CALIBRATOR | Jan 07, 1985 | Substantially Equivalent | Coulter Electronics, Inc. |
| K840794 | S-CAL HEMATOLOGY CALIBRATOR | Apr 04, 1984 | Substantially Equivalent | Coulter Electronics, Inc. |
| K821851 | CONTROL DIAGNOSTICS PLATELET CONTROL | Sep 02, 1982 | Substantially Equivalent | Immunogenetics |
| K781601 | TEKNI-CAL | Oct 10, 1978 | Substantially Equivalent | Streck Laboratories, Inc. |
| K781133 | PC-CALIBRATOR | Aug 14, 1978 | Substantially Equivalent | Streck Laboratories, Inc. |
| K770143 | TQC CALIBRATION REFERENCE FOR PLATELETS | Jan 30, 1978 | Substantially Equivalent | Technicon Instruments Corp. |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.