LFT · Class II · 21 CFR 862.3680

FDA Product Code LFT: Fluorescent Immunoassay, Primidone

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

8
Total
8
Cleared
35d
Avg days
1981
Since

FDA 510(k) Cleared Fluorescent Immunoassay, Primidone Devices (Product Code LFT)

8 devices
1–8 of 8
Cleared Mar 21, 1995
PRIMIDONE FPIA REAGENT SET AND CALIBRATORS
K950028
Sigma Diagnostics, Inc.
Toxicology · 76d
Cleared Nov 28, 1990
STRATUS PRIMIDONE FLUOROMETRIC ENZYME
K904683
Baxter Healthcare Corp
Chemistry · 44d
Cleared Jun 25, 1985
COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS
K852318
Roche Diagnostic Systems, Inc.
Toxicology · 25d
Cleared Jul 11, 1984
STRATUS PRIMIDONE FLOROMETRIC ENZY
K842196
American Dade
Toxicology · 37d
Cleared Jan 07, 1983
ADVANCE EMIT-AED PRIMEDONE ASSAY
K823741
Syva Co.
Chemistry · 25d
Cleared Aug 12, 1982
PRIMIDONE FLUORESCENT IMMUNOASSAY
K822229
American Diagnostic Corp.
Toxicology · 16d
Cleared Apr 29, 1981
AMES TDA TM PRIMIDONE TEST
K811007
Miles Laboratories, Inc.
Toxicology · 15d

About Product Code LFT - Regulatory Context