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

Fluorescence Polarization Immunoassay, Theophylline

21 CFR 862.3880 / Clinical Toxicology
FDA source (opens on fda.gov)

LGS is the FDA product code for Fluorescence Polarization Immunoassay, Theophylline, a class II device type, regulated under 21 CFR 862.3880. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LGS
Device name
Fluorescence Polarization Immunoassay, Theophylline
Regulation
21 CFR 862.3880
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
13
Ingested recalls
0

Clearances, product code LGS

By decision year
13 clearances under product code LGS with a decision year between 1985 and 2007, 1985 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LGS by decision year
YearClearances
19852
19872
19891
19901
19921
19931
19941
19952
19961
20071

Applicants with the most clearances

Product code LGS
Applicants holding the most 510(k) clearances under product code LGS
ApplicantClearances
Abbott Medical3
Roche Diagnostic Systems, Inc.2
American Monitor Corp.1
Biokit, S.A.1
Ciba Corning Diagnostics Corp.1
Colony Laboratories, Inc.1
Innotron Diagnostics1
Innotron of Oregon, Inc.1
Oxis Intl., Inc.1
Seradyn, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code