LFN · Class II · 21 CFR 862.3660

FDA Product Code LFN: Nephelometric Inhibition Immunoassay, Phenobarbital

Leading manufacturers include E.I. Dupont DE Nemours & Co., Inc., Electro-Nucleonics Laboratories, Inc. and Coulter Electronics, Inc..

5
Total
5
Cleared
58d
Avg days
1982
Since

FDA 510(k) Cleared Nephelometric Inhibition Immunoassay, Phenobarbital Devices (Product Code LFN)

5 devices
1–5 of 5
Cleared Feb 25, 1994
QMS PHENOBARBITAL
K934388
Seradyn, Inc.
Toxicology · 169d
Cleared Jan 13, 1987
DART PHENOBARBITAL ASSAY SYSTEM
K864612
Coulter Electronics, Inc.
Toxicology · 50d
Cleared Feb 28, 1986
DUPONT PHENOBARBITAL CALIBRATOR
K860303
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 31d
Cleared Feb 28, 1986
DUPONT PHENOBARBITAL ASSAY
K860304
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 31d
Cleared Jun 03, 1982
IPA FOR DETECTION OF PHENOBARBITAL
K821543
Electro-Nucleonics Laboratories, Inc.
Toxicology · 10d

About Product Code LFN - Regulatory Context