System, Test, Automated Blood Grouping And Antibody
This device is an automated blood grouping and antibody test system used in blood bank immunohematology to perform ABO and Rh blood typing along with antibody screening and identification in a high-throughput automated format, reducing manual labor and improving test consistency. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KSZ, regulated under 21 CFR 864.9175 within the Hematology specialty. No special flags apply.
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Basic Information
- Product Code
- KSZ
- Device Class
- FDA class 2
- Regulation Number
- 864.9175
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K810899 | TECHNICON AUTOGROUPER 16-C SYSTEM | May 05, 1981 | Substantially Equivalent | Technicon Instruments Corp. |
| K790282 | ELDONCARD | May 04, 1979 | Substantially Equivalent | Nordisk Infuser System |
| K771098 | BLOOD GROUPING SYS., BG-9 | Aug 04, 1977 | Substantially Equivalent | Technicon Instruments Corp. |
| K770185 | RH CONTROL DILUENT | Mar 14, 1977 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
FEI Numbers
This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.