FDA product code KSI: Lectins And Protectins
KSI is the FDA product code for lectins and protectins. It is a Class II device, regulated under 21 CFR 864.9550 and reviewed by the Hematology panel. FDA has cleared 4 510(k) submissions under KSI, from 2 different applicants. The average 510(k) review took 54 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Lectins And Protectins |
| Device class | Class II |
| Regulation | 21 CFR 864.9550 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KSI clearance
Top KSI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Dade | 2 | 1982-04-14 |
| Gamma Biologicals, Inc. | 2 | 1980-01-16 |
Most recent KSI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K820368 | American Dade | LECTIN-A | 1982-04-14 | 64 |
| K813413 | American Dade | LECTIN H | 1982-03-04 | 87 |
| K792582 | Gamma Biologicals, Inc. | POLY-LEC SYSTEM | 1980-01-16 | 33 |
| K792583 | Gamma Biologicals, Inc. | GAMMA ARACHIS HYPOGEA LECTIN | 1980-01-16 | 33 |
Recalls for KSI devices
openFDA lists no recalls for product code KSI.
Frequently asked questions
What is FDA product code KSI?
KSI is the FDA product code for lectins and protectins. It is a Class II device, regulated under 21 CFR 864.9550 and reviewed by the Hematology panel.
What device class is KSI?
Class II, regulation 21 CFR 864.9550. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KSI?
Across 4 cleared submissions the average was 54 days from receipt to decision (median 48).
Which companies have the most KSI clearances?
American Dade (2); Gamma Biologicals, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code KSI
- Run a recall and safety report across every KSI manufacturer
- Watch product code KSI 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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