FDA product code KSA: Calibrator For Red-Cell And White-Cell Counting
KSA is the FDA product code for calibrator for red-cell and white-cell counting. It is a Class II device, regulated under 21 CFR 864.8185 and reviewed by the Hematology panel. FDA has cleared 8 510(k) submissions under KSA, from 6 different applicants. The average 510(k) review took 73 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Calibrator For Red-Cell And White-Cell Counting |
| Device class | Class II |
| Regulation | 21 CFR 864.8185 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KSA clearance
Top KSA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| R&D Systems, Inc. | 3 | 1990-01-02 |
| Streck Laboratories, Inc. | 1 | 1994-12-15 |
| Technicon Instruments Corp. | 1 | 1987-02-06 |
| Hematology Marketing Assoc. | 1 | 1985-03-05 |
| American Dade | 1 | 1982-02-22 |
1 more applicants have KSA clearances. See the full list in Caduvo.
Most recent KSA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K943268 | Streck Laboratories, Inc. | SCS-1000 (SYSMEX CALIBRATOR SYSTEM) | 1994-12-15 | 161 |
| K897060 | R&D Systems, Inc. | CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE | 1990-01-02 | 15 |
| K881161 | R&D Systems, Inc. | TECH-CAL(TM)/MULTIPLE | 1988-05-02 | 45 |
| K864664 | Technicon Instruments Corp. | H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS | 1987-02-06 | 70 |
| K854823 | R&D Systems, Inc. | CBC-CAL/MULTIPLE | 1986-02-13 | 72 |
Recalls for KSA devices
openFDA lists no recalls for product code KSA.
Frequently asked questions
What is FDA product code KSA?
KSA is the FDA product code for calibrator for red-cell and white-cell counting. It is a Class II device, regulated under 21 CFR 864.8185 and reviewed by the Hematology panel.
What device class is KSA?
Class II, regulation 21 CFR 864.8185. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KSA?
Across 8 cleared submissions the average was 73 days from receipt to decision (median 68).
Which companies have the most KSA clearances?
R&D Systems, Inc. (3); Streck Laboratories, Inc. (1); Technicon Instruments Corp. (1); Hematology Marketing Assoc. (1); American Dade (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KSA
- Run a recall and safety report across every KSA manufacturer
- Watch product code KSA 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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