FDA product code LAT: Radioimmunoassay, Cannabinoid(S)
LAT is the FDA product code for radioimmunoassay, cannabinoid(s). It is a Class II device, regulated under 21 CFR 862.3870 and reviewed by the Clinical Toxicology panel. FDA has cleared 16 510(k) submissions under LAT, from 7 different applicants. The average 510(k) review took 122 days (median 57).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Cannabinoid(S) |
| Device class | Class II |
| Regulation | 21 CFR 862.3870 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LAT clearance
Top LAT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immunalysis Corporation | 7 | 1991-09-18 |
| Roche Diagnostic Systems, Inc. | 4 | 1996-06-13 |
| Psychemedics Corp. | 1 | 2002-05-03 |
| Sudormed, Inc. | 1 | 1996-06-10 |
| Diagnostic Products Corp. | 1 | 1991-12-18 |
2 more applicants have LAT clearances. See the full list in Caduvo.
Most recent LAT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K011426 | Psychemedics Corp. | PSYCHEMEDICS RIA CANNABINOID ASSAY | 2002-05-03 | 360 |
| K961620 | Roche Diagnostic Systems, Inc. | ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 | 1996-06-13 | 48 |
| K936135 | Sudormed, Inc. | SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION | 1996-06-10 | 895 |
| K914507 | Diagnostic Products Corp. | DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE | 1991-12-18 | 70 |
| K913414 | Roche Diagnostic Systems, Inc. | ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT | 1991-09-25 | 62 |
Recalls for LAT devices
openFDA lists no recalls for product code LAT.
Frequently asked questions
What is FDA product code LAT?
LAT is the FDA product code for radioimmunoassay, cannabinoid(s). It is a Class II device, regulated under 21 CFR 862.3870 and reviewed by the Clinical Toxicology panel.
What device class is LAT?
Class II, regulation 21 CFR 862.3870. Typical premarket route: 510(k).
How long does a 510(k) take for product code LAT?
Across 16 cleared submissions the average was 122 days from receipt to decision (median 57).
Which companies have the most LAT clearances?
Immunalysis Corporation (7); Roche Diagnostic Systems, Inc. (4); Psychemedics Corp. (1); Sudormed, Inc. (1); Diagnostic Products Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LAT
- Run a recall and safety report across every LAT manufacturer
- Watch product code LAT 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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