LFP · Class II · 21 CFR 862.1770

FDA Product Code LFP: Conductivity Rate, Urea Nitrogen

Leading manufacturers include Amresco, Inc., Sigma Chemical Co. and Sigma Diagnostics, Inc..

6
Total
6
Cleared
120d
Avg days
1981
Since

FDA 510(k) Cleared Conductivity Rate, Urea Nitrogen Devices (Product Code LFP)

6 devices
1–6 of 6
Cleared Jan 27, 2000
GAMBRO DQM 200
K990039
Gambro Healthcare
Chemistry · 386d
Cleared Oct 14, 1999
HICHEM BUN REAGENT
K992847
Elan Holdings, Inc.
Chemistry · 51d
Cleared Oct 24, 1996
SIGMA DIAGNOSTICS BUN REAGENT
K963537
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Dec 17, 1993
SIGMA BUN REAGENT
K933679
Sigma Chemical Co.
Chemistry · 142d
Cleared Nov 06, 1981
LIQUILYME BUN REAGENT
K812945
Amresco, Inc.
Chemistry · 17d

About Product Code LFP - Regulatory Context