FDA product code KSX: Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
KSX is the FDA product code for substance, blood grouping of non-human origin for in vitro diagnostic use. It is a Class II device, regulated under 21 CFR 864.9160 and reviewed by the Hematology panel. FDA has cleared 8 510(k) submissions under KSX, from 4 different applicants. The average 510(k) review took 49 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use |
| Device class | Class II |
| Regulation | 21 CFR 864.9160 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KSX clearance
Top KSX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| North American Biologicals, Inc. | 3 | 1978-12-20 |
| Gamma Biologicals, Inc. | 2 | 1980-11-12 |
| Ortho Diagnostics, Inc. | 2 | 1977-11-08 |
| Travenol Laboratories, S.A. | 1 | 1980-05-08 |
Most recent KSX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K802534 | Gamma Biologicals, Inc. | GAMMA PI BLOOD GROUP SUBSTANCE | 1980-11-12 | 28 |
| K802533 | Gamma Biologicals, Inc. | GAMMA LEWIS BLOOD GROUP SUBSTANCE | 1980-11-12 | 28 |
| K800916 | Travenol Laboratories, S.A. | P1 BLOOD GROUP SUBSTANCE | 1980-05-08 | 16 |
| K781862 | North American Biologicals, Inc. | BLOOD GROUP SUBSTANCE A | 1978-12-20 | 44 |
| K781895 | North American Biologicals, Inc. | BLOOD GROUP SUBSTANCE B | 1978-12-20 | 44 |
Recalls for KSX devices
openFDA lists no recalls for product code KSX.
Frequently asked questions
What is FDA product code KSX?
KSX is the FDA product code for substance, blood grouping of non-human origin for in vitro diagnostic use. It is a Class II device, regulated under 21 CFR 864.9160 and reviewed by the Hematology panel.
What device class is KSX?
Class II, regulation 21 CFR 864.9160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KSX?
Across 8 cleared submissions the average was 49 days from receipt to decision (median 44).
Which companies have the most KSX clearances?
North American Biologicals, Inc. (3); Gamma Biologicals, Inc. (2); Ortho Diagnostics, Inc. (2); Travenol Laboratories, S.A. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KSX
- Run a recall and safety report across every KSX manufacturer
- Watch product code KSX 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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