FDA product code KSL: Solution, Copper Sulfate For Specific Gravity Determinations
KSL is the FDA product code for solution, copper sulfate for specific gravity determinations. It is a Class I device, regulated under 21 CFR 864.9320 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under KSL, from 2 different applicants. The average 510(k) review took 70 days (median 70).
Classification
| Field | Value |
|---|---|
| Device name | Solution, Copper Sulfate For Specific Gravity Determinations |
| Device class | Class I |
| Regulation | 21 CFR 864.9320 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KSL clearance
Top KSL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Portable Medical Laboratories, Inc. | 1 | 1988-07-01 |
| Accra Laboratories, Inc. | 1 | 1981-03-06 |
Most recent KSL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K882101 | Portable Medical Laboratories, Inc. | HEMOGLOBIN SCREENING DEVICE | 1988-07-01 | 51 |
| K803095 | Accra Laboratories, Inc. | COPPER SULFATE SOLUTION SP. GR.1.055 | 1981-03-06 | 88 |
Recalls for KSL devices
openFDA lists no recalls for product code KSL.
Frequently asked questions
What is FDA product code KSL?
KSL is the FDA product code for solution, copper sulfate for specific gravity determinations. It is a Class I device, regulated under 21 CFR 864.9320 and reviewed by the Hematology panel.
What device class is KSL?
Class I, regulation 21 CFR 864.9320. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KSL?
Across 2 cleared submissions the average was 70 days from receipt to decision (median 70).
Which companies have the most KSL clearances?
Portable Medical Laboratories, Inc. (1); Accra Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KSL
- Run a recall and safety report across every KSL manufacturer
- Watch product code KSL 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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