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

Fluorescence Polarization Immunoassay, Tobramycin

21 CFR 862.3900 / Clinical Toxicology
FDA source (opens on fda.gov)

LFW is the FDA product code for Fluorescence Polarization Immunoassay, Tobramycin, a class II device type, regulated under 21 CFR 862.3900. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
LFW
Device name
Fluorescence Polarization Immunoassay, Tobramycin
Regulation
21 CFR 862.3900
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
10
Ingested recalls
2

Clearances, product code LFW

By decision year
10 clearances under product code LFW with a decision year between 1984 and 1997, 1985 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LFW by decision year
YearClearances
19841
19852
19871
19891
19901
19911
19942
19971

Applicants with the most clearances

Product code LFW
Applicants holding the most 510(k) clearances under product code LFW
ApplicantClearances
Innotron of Oregon, Inc.2
Roche Diagnostic Systems, Inc.2
Abbott Medical1
Colony Laboratories, Inc.1
Innotron Diagnostics1
Microgenics Corporation1
Sigma Diagnostics, Inc.1
Windsor Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code