LGI · Class II · 21 CFR 862.3645

FDA Product Code LGI: Fluorescence Polarization Immunoassay, Carbamazepine

Leading manufacturers include Innotron of Oregon, Inc., Abbott Laboratories and Sigma Diagnostics, Inc..

3
Total
3
Cleared
91d
Avg days
1990
Since

FDA 510(k) Cleared Fluorescence Polarization Immunoassay, Carbamazepine Devices (Product Code LGI)

3 devices
1–3 of 3
Cleared Nov 10, 1994
FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE
K944063
Sigma Diagnostics, Inc.
Chemistry · 83d
Cleared Jun 21, 1994
AXSYM(TM) QUINIDINE
K940682
Abbott Laboratories
Chemistry · 131d
Cleared Apr 12, 1990
MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA
K900702
Innotron of Oregon, Inc.
Toxicology · 59d

About Product Code LGI - Regulatory Context