LGQ · Class II · 21 CFR 862.3660

FDA Product Code LGQ: Fluorescence Polarization Immunoassay, Phenobarbital

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

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 Aug 01, 1997
INNOFLUOR GENTAMICIN ASSAY SYSTEM
K972331
Oxis Intl., Inc.
Toxicology · 39d
Cleared Jul 14, 1997
INNOFLUOR PHENOBARBITAL ASSAY SYSTEM
K972330
Oxis Intl., Inc.
Toxicology · 21d
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 Apr 12, 1990
MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA
K900704
Innotron of Oregon, Inc.
Toxicology · 59d
Cleared Jul 21, 1987
COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.
K872397
Roche Diagnostic Systems, Inc.
Toxicology · 29d
Cleared Nov 10, 1986
PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT
K863625
Windsor Laboratories, Inc.
Toxicology · 54d
Cleared Jul 16, 1986
IMMPULSE PHENOBARBITAL ASSAY REAGENTS
K862528
Sclavo, Inc.
Toxicology · 14d
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