Calibrator For Red-Cell And White-Cell Counting
This device is a calibrator used to standardize automated hematology analyzers for red blood cell and white blood cell counting, ensuring accurate quantification of cellular elements in blood for diagnostic evaluation of hematological conditions. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KSA, regulated under 21 CFR 864.8185 within the Hematology specialty. No special flags apply.
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Basic Information
- Product Code
- KSA
- Device Class
- FDA class 2
- Regulation Number
- 864.8185
- 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 |
|---|---|---|---|---|
| K943268 | SCS-1000 (SYSMEX CALIBRATOR SYSTEM) | Dec 15, 1994 | Substantially Equivalent | Streck Laboratories, Inc. |
| K897060 | CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE | Jan 02, 1990 | Substantially Equivalent | R&D Systems, Inc. |
| K881161 | TECH-CAL(TM)/MULTIPLE | May 02, 1988 | Substantially Equivalent | R&D Systems, Inc. |
| K864664 | H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS | Feb 06, 1987 | Substantially Equivalent | Technicon Instruments Corp. |
| K854823 | CBC-CAL/MULTIPLE | Feb 13, 1986 | Substantially Equivalent | R&D Systems, Inc. |
| K844708 | TRI-COUNT CALIBRATOR | Mar 05, 1985 | Substantially Equivalent | Hematology Marketing Assoc. |
| K813530 | HEMOTOLOGY CALIBRATOR | Feb 22, 1982 | Substantially Equivalent | American Dade |
| K813375 | HEMATOLOGY CALIBRATOR S-CAL | Feb 04, 1982 | Substantially Equivalent | Coulter Electronics, Inc. |
FEI Numbers
This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.