FDA product code LKZ: Red-Cell Count By Photometry
LKZ is the FDA product code for red-cell count by photometry. It is a Class II device, regulated under 21 CFR 864.7100 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under LKZ, from 2 different applicants. The average 510(k) review took 74 days (median 74).
Classification
| Field | Value |
|---|---|
| Device name | Red-Cell Count By Photometry |
| Device class | Class II |
| Regulation | 21 CFR 864.7100 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Top LKZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Worthington Diagnostic Systems | 1 | 1984-01-04 |
| Bio-Analytics Laboratories, Inc. | 1 | 1983-10-28 |
Most recent LKZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K833708 | Worthington Diagnostic Systems | COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE | 1984-01-04 | 76 |
| K832771 | Bio-Analytics Laboratories, Inc. | ERYTHROCYTE TEST | 1983-10-28 | 73 |
Recalls for LKZ devices
openFDA lists no recalls for product code LKZ.
Frequently asked questions
What is FDA product code LKZ?
LKZ is the FDA product code for red-cell count by photometry. It is a Class II device, regulated under 21 CFR 864.7100 and reviewed by the Hematology panel.
What device class is LKZ?
Class II, regulation 21 CFR 864.7100. Typical premarket route: 510(k).
How long does a 510(k) take for product code LKZ?
Across 2 cleared submissions the average was 74 days from receipt to decision (median 74).
Which companies have the most LKZ clearances?
Worthington Diagnostic Systems (1); Bio-Analytics Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LKZ
- Run a recall and safety report across every LKZ manufacturer
- Watch product code LKZ 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.