DLP · Class II · 21 CFR 862.3350

FDA Product Code DLP: Radioimmunoassay, Diphenylhydantoin

Leading manufacturers include Amersham Corp., Ventrex Laboratories, Inc. and Bio-Rad.

5
Total
5
Cleared
34d
Avg days
1977
Since

FDA 510(k) Cleared Radioimmunoassay, Diphenylhydantoin Devices (Product Code DLP)

5 devices
1–5 of 5
Cleared Sep 25, 1989
FPR PHENYTOIN KIT
K894527
Colony Laboratories, Inc.
Toxicology · 67d
Cleared Jul 10, 1981
KALLESTAD ANTISERA TO PHENYTOIN
K811775
Kallestad Laboratories, Inc.
Toxicology · 17d
Cleared Jan 11, 1980
FLUOROMATIC PHENYTOIN FIA
K792640
Bio-Rad
Toxicology · 15d
Cleared Oct 17, 1979
CENTRIA PHENYTOIN RIA TEST SET
K791896
Ventrex Laboratories, Inc.
Toxicology · 22d
Cleared Jun 17, 1977
PHENYTOIN RIA KIT
K770779
Amersham Corp.
Toxicology · 49d

About Product Code DLP - Regulatory Context