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

Fluorescence Polarization Immunoassay, Phenobarbital

21 CFR 862.3660 / Clinical Toxicology
FDA source (opens on fda.gov)

LGQ is the FDA product code for Fluorescence Polarization Immunoassay, Phenobarbital, a class II device type, regulated under 21 CFR 862.3660. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
LGQ
Device name
Fluorescence Polarization Immunoassay, Phenobarbital
Regulation
21 CFR 862.3660
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
12
Ingested recalls
2

Clearances, product code LGQ

By decision year
12 clearances under product code LGQ with a decision year between 1984 and 1997, 1985 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LGQ by decision year
YearClearances
19841
19852
19862
19871
19891
19901
19942
19972

Applicants with the most clearances

Product code LGQ
Applicants holding the most 510(k) clearances under product code LGQ
ApplicantClearances
Roche Diagnostic Systems, Inc.3
Abbott Medical2
Oxis Intl., Inc.2
Colony Laboratories, Inc.1
Innotron Diagnostics1
Innotron of Oregon, Inc.1
Sclavo, Inc.1
Windsor Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code