FDA product code KSZ: System, Test, Automated Blood Grouping And Antibody
KSZ is the FDA product code for system, test, automated blood grouping and antibody. It is a Class II device, regulated under 21 CFR 864.9175 and reviewed by the Hematology panel. FDA has cleared 4 510(k) submissions under KSZ, from 3 different applicants. The average 510(k) review took 51 days (median 46).
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Automated Blood Grouping And Antibody |
| Device class | Class II |
| Regulation | 21 CFR 864.9175 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every KSZ clearance
Top KSZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Technicon Instruments Corp. | 2 | 1981-05-05 |
| Nordisk Infuser System | 1 | 1979-05-04 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1977-03-14 |
Most recent KSZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K810899 | Technicon Instruments Corp. | TECHNICON AUTOGROUPER 16-C SYSTEM | 1981-05-05 | 32 |
| K790282 | Nordisk Infuser System | ELDONCARD | 1979-05-04 | 80 |
| K771098 | Technicon Instruments Corp. | BLOOD GROUPING SYS., BG-9 | 1977-08-04 | 45 |
| K770185 | Bd Becton Dickinson Vacutainer Systems Preanalytic | RH CONTROL DILUENT | 1977-03-14 | 46 |
Recalls for KSZ devices
openFDA lists no recalls for product code KSZ.
Frequently asked questions
What is FDA product code KSZ?
KSZ is the FDA product code for system, test, automated blood grouping and antibody. It is a Class II device, regulated under 21 CFR 864.9175 and reviewed by the Hematology panel.
What device class is KSZ?
Class II, regulation 21 CFR 864.9175. Typical premarket route: 510(k).
How long does a 510(k) take for product code KSZ?
Across 4 cleared submissions the average was 51 days from receipt to decision (median 46).
Which companies have the most KSZ clearances?
Technicon Instruments Corp. (2); Nordisk Infuser System (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KSZ
- Run a recall and safety report across every KSZ manufacturer
- Watch product code KSZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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