FDA product code LET: Fluorescent Immunoassay, Phenobarbital
LET is the FDA product code for fluorescent immunoassay, phenobarbital. It is a Class II device, regulated under 21 CFR 862.3660 and reviewed by the Clinical Toxicology panel. FDA has cleared 8 510(k) submissions under LET, from 6 different applicants. The average 510(k) review took 35 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Fluorescent Immunoassay, Phenobarbital |
| Device class | Class II |
| Regulation | 21 CFR 862.3660 |
| 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 LET clearance
Top LET applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Miles Laboratories, Inc. | 3 | 1984-08-17 |
| Pb Diagnostic Systems, Inc. | 1 | 1990-06-12 |
| Sclavo, Inc. | 1 | 1987-02-06 |
| American Dade | 1 | 1983-05-13 |
| American Diagnostic Corp. | 1 | 1982-05-24 |
1 more applicants have LET clearances. See the full list in Caduvo.
Most recent LET clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K901537 | Pb Diagnostic Systems, Inc. | MODIFIED OPUS PHENOBARBITAL TEST SYSTEM | 1990-06-12 | 71 |
| K865000 | Sclavo, Inc. | IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS | 1987-02-06 | 46 |
| K842592 | Miles Laboratories, Inc. | AMES TDA PHENOBARBITAL TEST | 1984-08-17 | 45 |
| K830701 | American Dade | STRATUS PHENOBARBITAL FLUOROMETRIC ENZ | 1983-05-13 | 67 |
| K821408 | American Diagnostic Corp. | PHENOBARBITAL FLUORESCENT IMMUNO | 1982-05-24 | 13 |
Recalls for LET devices
openFDA lists no recalls for product code LET.
Frequently asked questions
What is FDA product code LET?
LET is the FDA product code for fluorescent immunoassay, phenobarbital. It is a Class II device, regulated under 21 CFR 862.3660 and reviewed by the Clinical Toxicology panel.
What device class is LET?
Class II, regulation 21 CFR 862.3660. Typical premarket route: 510(k).
How long does a 510(k) take for product code LET?
Across 8 cleared submissions the average was 35 days from receipt to decision (median 30).
Which companies have the most LET clearances?
Miles Laboratories, Inc. (3); Pb Diagnostic Systems, Inc. (1); Sclavo, Inc. (1); American Dade (1); American Diagnostic Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LET
- Run a recall and safety report across every LET manufacturer
- Watch product code LET 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 Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times