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

Fluorescence Polarization Immunoassay, Amibacin

21 CFR 862.3035 / Clinical Toxicology
FDA source (opens on fda.gov)

LGJ is the FDA product code for Fluorescence Polarization Immunoassay, Amibacin, a class II device type, regulated under 21 CFR 862.3035. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LGJ
Device name
Fluorescence Polarization Immunoassay, Amibacin
Regulation
21 CFR 862.3035
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
3
Ingested recalls
0

Clearances, product code LGJ

By decision year
3 clearances under product code LGJ with a decision year between 1986 and 1999, 1986 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LGJ by decision year
YearClearances
19861
19941
19991

Applicants with the most clearances

Product code LGJ
Applicants holding the most 510(k) clearances under product code LGJ
ApplicantClearances
Roche Diagnostic Systems, Inc.1
Roche Diagnostics GmbH1
Windsor Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code