LETClass II

Fluorescent Immunoassay, Phenobarbital

21 CFR 862.3660 / Clinical Toxicology

LET is the FDA product code for Fluorescent Immunoassay, Phenobarbital, a class II device type, regulated under 21 CFR 862.3660. As of 2026-09-10, FDA records hold 8 510(k) clearances under this code, the most recent dated 1990-06-12, and no recalls.

Classification record

Product code: LET
Device name: Fluorescent Immunoassay, Phenobarbital
Regulation: 21 CFR 862.3660
Device class: Class II
Review panel: Clinical Toxicology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 8
Ingested recalls: 0

Clearances, product code LET

By decision year

8 clearances under product code LET with a decision year between 1980 and 1990, 1982 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code LET by decision year
Year	Clearances
1980	1
1981	1
1982	2
1983	1
1984	1
1987	1
1990	1

Applicants with the most clearances

Product code LET

Applicants holding the most 510(k) clearances under product code LET
Applicant	Clearances
Miles Laboratories, Inc.	3
American Dade	1
American Diagnostic Corp.	1
Pb Diagnostic Systems, Inc.	1
Sclavo, Inc.	1
Syva Co.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LET.