FDA product code LCL: Radioimmunoassay, Phencyclidine
LCL is the FDA product code for radioimmunoassay, phencyclidine. It is a Unclassified device, reviewed by the Clinical Toxicology panel. FDA has cleared 11 510(k) submissions under LCL, from 7 different applicants. The average 510(k) review took 61 days (median 38).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Phencyclidine |
| Device class | Unclassified |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every LCL clearance
Top LCL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immunalysis Corporation | 2 | 1991-10-11 |
| Syva Co. | 2 | 1988-07-12 |
| Abbott Laboratories | 2 | 1988-02-11 |
| Hoffmann-La Roche, Inc. | 2 | 1983-03-24 |
| Psychemedics Corp. | 1 | 2002-02-11 |
2 more applicants have LCL clearances. See the full list in Caduvo.
Most recent LCL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K011275 | Psychemedics Corp. | PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY | 2002-02-11 | 291 |
| K994093 | Phamatech | AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C | 1999-12-16 | 13 |
| K913864 | Immunalysis Corporation | PCP DIRECT RIA KIT (I-125) | 1991-10-11 | 45 |
| K890882 | Roche Diagnostic Systems, Inc. | ABUSCREEN FP FOR PHENCYCLIDINE | 1989-03-15 | 22 |
| K882179 | Syva Co. | EMIT HVA PHENCYCLIDINE ASSAY | 1988-07-12 | 49 |
Recalls for LCL devices
openFDA lists no recalls for product code LCL.
Frequently asked questions
What is FDA product code LCL?
LCL is the FDA product code for radioimmunoassay, phencyclidine. It is a Unclassified device, reviewed by the Clinical Toxicology panel.
What device class is LCL?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LCL?
Across 11 cleared submissions the average was 61 days from receipt to decision (median 38).
Which companies have the most LCL clearances?
Immunalysis Corporation (2); Syva Co. (2); Abbott Laboratories (2); Hoffmann-La Roche, Inc. (2); Psychemedics Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LCL
- Run a recall and safety report across every LCL manufacturer
- Watch product code LCL 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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