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

Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)

21 CFR 862.3350 / Clinical Toxicology
FDA source (opens on fda.gov)

LGR is the FDA product code for Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total), a class II device type, regulated under 21 CFR 862.3350. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LGR
Device name
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
Regulation
21 CFR 862.3350
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
15
Ingested recalls
0

Clearances, product code LGR

By decision year
15 clearances under product code LGR with a decision year between 1984 and 1996, 1984 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LGR by decision year
YearClearances
19843
19851
19861
19871
19891
19901
19943
19952
19962

Applicants with the most clearances

Product code LGR
Applicants holding the most 510(k) clearances under product code LGR
ApplicantClearances
Abbott Medical3
Innotron of Oregon, Inc.2
Roche Diagnostic Systems, Inc.2
BD Becton Dickinson Vacutainer Systems Preanalytic1
Ciba Corning Diagnostics Corp.1
Innotron Diagnostics1
Oxis Intl., Inc.1
Pb Diagnostic Systems, Inc.1
Sclavo, Inc.1
Sigma Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code