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

Enzyme Immunoassay, Digitoxin

21 CFR 862.3300 / Clinical Toxicology
FDA source (opens on fda.gov)

LFM is the FDA product code for Enzyme Immunoassay, Digitoxin, a class II device type, regulated under 21 CFR 862.3300. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
LFM
Device name
Enzyme Immunoassay, Digitoxin
Regulation
21 CFR 862.3300
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
20
Ingested recalls
5

Clearances, product code LFM

By decision year
20 clearances under product code LFM with a decision year between 1983 and 2006, 1994 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LFM by decision year
YearClearances
19831
19842
19861
19892
19901
19912
19921
19943
19952
19961
19971
19991
20021
20061

Applicants with the most clearances

Product code LFM
Applicants holding the most 510(k) clearances under product code LFM
ApplicantClearances
Siemens Healthcare Diagnostics Inc.6
Abbott Medical3
American Dade1
Bayer Corp.1
Chiron Diagnostics Corp.1
E.I. Dupont de Nemours & Co., Inc.1
Eastman Kodak Company1
Intl. Bioclinical, Inc.1
Microgenics Corporation1
Randox Laboratories, Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code