FDA product code KSK: Solution, Stabilized Enzyme
KSK is the FDA product code for solution, stabilized enzyme. It is a Class II device, regulated under 21 CFR 864.9400 and reviewed by the Hematology panel. FDA has cleared 5 510(k) submissions under KSK, from 4 different applicants. The average 510(k) review took 70 days (median 65).
Classification
| Field | Value |
|---|---|
| Device name | Solution, Stabilized Enzyme |
| Device class | Class II |
| Regulation | 21 CFR 864.9400 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KSK clearance
Top KSK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biological Corp. of America | 2 | 1982-02-10 |
| Gamma Biologicals, Inc. | 1 | 1982-03-04 |
| Hyland Therapeutic Div., Travenol Laboratories | 1 | 1978-07-27 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1976-07-20 |
Most recent KSK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K813342 | Gamma Biologicals, Inc. | GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION | 1982-03-04 | 99 |
| K813404 | Biological Corp. of America | FREEZE DRIED FICIN | 1982-02-10 | 65 |
| K810803 | Biological Corp. of America | FREEZE DRIED PAPAIN | 1981-07-21 | 119 |
| K780962 | Hyland Therapeutic Div., Travenol Laboratories | AUTOMATED ENZYME | 1978-07-27 | 45 |
| K760123 | Bd Becton Dickinson Vacutainer Systems Preanalytic | AUTOZYME | 1976-07-20 | 22 |
Recalls for KSK devices
openFDA lists no recalls for product code KSK.
Frequently asked questions
What is FDA product code KSK?
KSK is the FDA product code for solution, stabilized enzyme. It is a Class II device, regulated under 21 CFR 864.9400 and reviewed by the Hematology panel.
What device class is KSK?
Class II, regulation 21 CFR 864.9400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KSK?
Across 5 cleared submissions the average was 70 days from receipt to decision (median 65).
Which companies have the most KSK clearances?
Biological Corp. of America (2); Gamma Biologicals, Inc. (1); Hyland Therapeutic Div., Travenol Laboratories (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KSK
- Run a recall and safety report across every KSK manufacturer
- Watch product code KSK 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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