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

Fluorescence Polarization Immunoassay, Carbamazepine

21 CFR 862.3645 / Clinical Toxicology
FDA source (opens on fda.gov)

LGI is the FDA product code for Fluorescence Polarization Immunoassay, Carbamazepine, a class II device type, regulated under 21 CFR 862.3645. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
LGI
Device name
Fluorescence Polarization Immunoassay, Carbamazepine
Regulation
21 CFR 862.3645
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
4

Clearances, product code LGI

By decision year
3 clearances under product code LGI with a decision year between 1990 and 1994, 1994 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LGI by decision year
YearClearances
19901
19942

Applicants with the most clearances

Product code LGI
Applicants holding the most 510(k) clearances under product code LGI
ApplicantClearances
Abbott Medical1
Innotron of Oregon, Inc.1
Sigma Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code