LES · Class II · 21 CFR 862.3350

FDA Product Code LES: Fluorescent Immunoassay, Diphenylhydantoin

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

7
Total
7
Cleared
22d
Avg days
1980
Since

FDA 510(k) Cleared Fluorescent Immunoassay, Diphenylhydantoin Devices (Product Code LES)

7 devices
1–7 of 7
Cleared Jan 13, 1987
IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS
K865102
Sclavo, Inc.
Toxicology · 20d
Cleared Jan 23, 1985
SYVA ADVANCE EMIT PHENYTOIN ASSAY
K844990
Syva Co.
Toxicology · 28d
Cleared May 16, 1983
STRATUS PHENYTOIN FLUOROMETRIC ENZYME
K831154
American Dade
Immunology · 38d
Cleared Feb 12, 1982
SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY
K820187
Syva Co.
Toxicology · 18d
Cleared Apr 29, 1981
AMES TDA TM PHENYTOIN TEST
K811025
Miles Laboratories, Inc.
Toxicology · 13d
Cleared Aug 20, 1980
AMES TDA TM PHENYTOIN TEST
K801736
Miles Laboratories, Inc.
Toxicology · 26d

About Product Code LES - Regulatory Context