FDA product code KSF: Kit, Quality Control For Blood Banking Reagents
KSF is the FDA product code for kit, quality control for blood banking reagents. It is a Class II device, regulated under 21 CFR 864.9650 and reviewed by the Hematology panel. FDA has cleared 12 510(k) submissions under KSF, from 11 different applicants. The average 510(k) review took 47 days (median 32).
Classification
| Field | Value |
|---|---|
| Device name | Kit, Quality Control For Blood Banking Reagents |
| Device class | Class II |
| Regulation | 21 CFR 864.9650 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every KSF clearance
Top KSF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ortho Diagnostics, Inc. | 2 | 1980-03-05 |
| Ortho Diagnostic Systems, Inc. | 1 | 1981-10-23 |
| American Dade | 1 | 1981-03-31 |
| North American Biologicals, Inc. | 1 | 1980-07-14 |
| Gamma Biologicals, Inc. | 1 | 1980-04-16 |
6 more applicants have KSF clearances. See the full list in Caduvo.
Most recent KSF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K811713 | Ortho Diagnostic Systems, Inc. | AVI-D CONTROL | 1981-10-23 | 128 |
| K810599 | American Dade | DADE RH CONTROL REAGENT | 1981-03-31 | 25 |
| K801425 | North American Biologicals, Inc. | RH CONTROL | 1980-07-14 | 27 |
| K800658 | Gamma Biologicals, Inc. | RST-SERIES CONTROL | 1980-04-16 | 21 |
| K800310 | Ortho Diagnostics, Inc. | ORTHO ANTISERA CONTROL | 1980-03-05 | 22 |
Recalls for KSF devices
openFDA lists no recalls for product code KSF.
Frequently asked questions
What is FDA product code KSF?
KSF is the FDA product code for kit, quality control for blood banking reagents. It is a Class II device, regulated under 21 CFR 864.9650 and reviewed by the Hematology panel.
What device class is KSF?
Class II, regulation 21 CFR 864.9650. Typical premarket route: 510(k).
How long does a 510(k) take for product code KSF?
Across 12 cleared submissions the average was 47 days from receipt to decision (median 32).
Which companies have the most KSF clearances?
Ortho Diagnostics, Inc. (2); Ortho Diagnostic Systems, Inc. (1); American Dade (1); North American Biologicals, Inc. (1); Gamma Biologicals, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KSF
- Run a recall and safety report across every KSF manufacturer
- Watch product code KSF 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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