FDA product code LIZ: Assay, T Lymphocyte Surface Marker
LIZ is the FDA product code for assay, t lymphocyte surface marker. It is a Class II device, regulated under 21 CFR 864.5220 and reviewed by the Immunology panel. FDA has cleared 7 510(k) submissions under LIZ, from 6 different applicants. The average 510(k) review took 177 days (median 187). FDA has posted 1 recall for LIZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Assay, T Lymphocyte Surface Marker |
| Device class | Class II |
| Regulation | 21 CFR 864.5220 |
| Review panel | IM — Immunology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LIZ clearance
Top LIZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 1985-04-03 |
| Gen Trak, Inc. | 1 | 1992-06-19 |
| Technicon Instruments Corp. | 1 | 1986-09-08 |
| Control Diagnostics | 1 | 1984-02-03 |
| Bio-Rad | 1 | 1983-08-08 |
1 more applicants have LIZ clearances. See the full list in Caduvo.
Most recent LIZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K914847 | Gen Trak, Inc. | CD8 MONOCLONAL ANTIBODIES | 1992-06-19 | 235 |
| K860830 | Technicon Instruments Corp. | TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD | 1986-09-08 | 187 |
| K843062 | Bd Becton Dickinson Vacutainer Systems Preanalytic | TBM-REAGENT FOR T,B CELL & MONOCYTES | 1985-04-03 | 243 |
| K842218 | Bd Becton Dickinson Vacutainer Systems Preanalytic | ANTI-LEU-4 FITC LYSIN C BUFFER | 1984-12-27 | 206 |
| K833929 | Control Diagnostics | WHITE BLOOD CELLS HUMAN TAND B | 1984-02-03 | 108 |
Recalls for LIZ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-09-30.
Frequently asked questions
What is FDA product code LIZ?
LIZ is the FDA product code for assay, t lymphocyte surface marker. It is a Class II device, regulated under 21 CFR 864.5220 and reviewed by the Immunology panel.
What device class is LIZ?
Class II, regulation 21 CFR 864.5220. Typical premarket route: 510(k).
How long does a 510(k) take for product code LIZ?
Across 7 cleared submissions the average was 177 days from receipt to decision (median 187).
Which companies have the most LIZ clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (2); Gen Trak, Inc. (1); Technicon Instruments Corp. (1); Control Diagnostics (1); Bio-Rad (1).
Have LIZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-09-30.
Next steps
- Run an FDA pathway report with predicate devices for product code LIZ
- Run a recall and safety report across every LIZ manufacturer
- Watch product code LIZ 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.
All Immunology product codes · FDA product code lookup · 510(k) database search · 510(k) review times