510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LFNClass II

Nephelometric Inhibition Immunoassay, Phenobarbital

21 CFR 862.3660 / Clinical Toxicology
FDA source (opens on fda.gov)

LFN is the FDA product code for Nephelometric Inhibition Immunoassay, Phenobarbital, a class II device type, regulated under 21 CFR 862.3660. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LFN
Device name
Nephelometric Inhibition 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
5
Ingested recalls
0

Clearances, product code LFN

By decision year
5 clearances under product code LFN with a decision year between 1982 and 1994, 1986 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LFN by decision year
YearClearances
19821
19862
19871
19941

Applicants with the most clearances

Product code LFN
Applicants holding the most 510(k) clearances under product code LFN
ApplicantClearances
E.I. Dupont de Nemours & Co., Inc.2
Coulter Electronics, Inc.1
Electro-Nucleonics Laboratories, Inc.1
Seradyn, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code