510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
LFOClass II

Nephelometric Inhibition Immunoassay, Diphenylhydantoin

21 CFR 862.3350 / Clinical Toxicology
FDA source (opens on fda.gov)

LFO is the FDA product code for Nephelometric Inhibition Immunoassay, Diphenylhydantoin, a class II device type, regulated under 21 CFR 862.3350. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
LFO
Device name
Nephelometric Inhibition Immunoassay, Diphenylhydantoin
Regulation
21 CFR 862.3350
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
1
Ingested recalls
0

Clearances, product code LFO

By decision year
1 clearance under product code LFO with a decision year between 1988 and 1988, 1988 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LFO by decision year
YearClearances
19881

Applicants with the most clearances

Product code LFO
Applicants holding the most 510(k) clearances under product code LFO
ApplicantClearances
Coulter Electronics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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