LET · Class II · 21 CFR 862.3660

FDA Product Code LET: Fluorescent Immunoassay, Phenobarbital

Leading manufacturers include Miles Laboratories, Inc., Syva Co. and American Diagnostic Corp..

8
Total
8
Cleared
35d
Avg days
1980
Since

FDA 510(k) Cleared Fluorescent Immunoassay, Phenobarbital Devices (Product Code LET)

8 devices
1–8 of 8
Cleared Jun 12, 1990
MODIFIED OPUS PHENOBARBITAL TEST SYSTEM
K901537
Pb Diagnostic Systems, Inc.
Toxicology · 71d
Cleared Feb 06, 1987
IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS
K865000
Sclavo, Inc.
Toxicology · 46d
Cleared Aug 17, 1984
AMES TDA PHENOBARBITAL TEST
K842592
Miles Laboratories, Inc.
Toxicology · 45d
Cleared May 13, 1983
STRATUS PHENOBARBITAL FLUOROMETRIC ENZ
K830701
American Dade
Toxicology · 67d
Cleared May 24, 1982
PHENOBARBITAL FLUORESCENT IMMUNO
K821408
American Diagnostic Corp.
Toxicology · 13d
Cleared Feb 05, 1982
PHENOBARBITAL ASSAY
K820188
Syva Co.
Toxicology · 11d
Cleared Apr 29, 1981
AMES TDA TM PHENOBARBITAL TEST
K810994
Miles Laboratories, Inc.
Toxicology · 16d
Cleared Sep 26, 1980
AMES TDA PHENOBARBITAL TEST
K802255
Miles Laboratories, Inc.
Toxicology · 10d

About Product Code LET - Regulatory Context