LGQ · Class II · 21 CFR 862.3660

FDA Product Code LGQ: Fluorescence Polarization Immunoassay, Phenobarbital

Leading manufacturers include Roche Diagnostic Systems, Inc. and Abbott Laboratories.

12
Total
12
Cleared
54d
Avg days
1984
Since

FDA 510(k) Cleared Fluorescence Polarization Immunoassay, Phenobarbital Devices (Product Code LGQ)

12 devices
1–12 of 12
Cleared Jun 21, 1994
AXSYM PHENOBARBITAL
K940596
Abbott Laboratories
Toxicology · 131d
Cleared Mar 11, 1994
COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS
K936130
Roche Diagnostic Systems, Inc.
Toxicology · 78d
Cleared Jul 21, 1987
COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.
K872397
Roche Diagnostic Systems, Inc.
Toxicology · 29d
Cleared Oct 28, 1985
TDX BARBITURATES
K854044
Abbott Laboratories
Toxicology · 26d
Cleared Feb 01, 1985
COBAS REAGENTS PHENOBARBITAL & PHENOBAR
K843825
Roche Diagnostic Systems, Inc.
Toxicology · 126d

About Product Code LGQ - Regulatory Context