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

Fluorescent Immunoassay, Primidone

21 CFR 862.3680 / Clinical Toxicology
FDA source (opens on fda.gov)

LFT is the FDA product code for Fluorescent Immunoassay, Primidone, a class II device type, regulated under 21 CFR 862.3680. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LFT
Device name
Fluorescent Immunoassay, Primidone
Regulation
21 CFR 862.3680
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 LFT

By decision year
8 clearances under product code LFT with a decision year between 1981 and 1995, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LFT by decision year
YearClearances
19811
19821
19831
19841
19851
19891
19901
19951

Applicants with the most clearances

Product code LFT
Applicants holding the most 510(k) clearances under product code LFT
ApplicantClearances
American Dade1
American Diagnostic Corp.1
Baxter Healthcare Corporation1
Miles Laboratories, Inc.1
Roche Diagnostic Systems, Inc.1
Sigma Diagnostics, Inc.1
Syva Co.1
Tudor Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code