LGR · Class II · 21 CFR 862.3350

FDA Product Code LGR: Fluorescence Polarization Immunoassay, Diphenylhydantoin (total)

Leading manufacturers include Abbott Laboratories, Roche Diagnostic Systems, Inc. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

15
Total
15
Cleared
72d
Avg days
1984
Since

FDA 510(k) Cleared Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) Devices (Product Code LGR)

15 devices
1–15 of 15
Cleared Mar 11, 1996
ACS PHENYTOIN ASSAY
K955873
Ciba Corning Diagnostics Corp.
Toxicology · 76d
Cleared Sep 25, 1995
AXSYM PHENYTOIN II
K953840
Abbott Laboratories
Toxicology · 40d
Cleared Mar 28, 1995
TDX(R)/TDXFLX(R) PHENYTOIN II
K946328
Abbott Laboratories
Toxicology · 89d
Cleared Oct 27, 1994
PHENYTOIN FPIA REAGENT SET AND CALIBRATORS
K943313
Sigma Diagnostics, Inc.
Toxicology · 108d
Cleared Jun 21, 1994
AXSYM PHENYTOIN ASSAY
K935375
Abbott Laboratories
Toxicology · 225d
Cleared Mar 11, 1994
COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS
K936131
Roche Diagnostic Systems, Inc.
Toxicology · 78d
Cleared Feb 01, 1985
COBAS FP REAGENTS FOR PHENYTOIN & CALIBR
K843824
Roche Diagnostic Systems, Inc.
Toxicology · 126d
Cleared Dec 10, 1984
PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE
K844171
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 46d

About Product Code LGR - Regulatory Context