LFT · Class II · 21 CFR 862.3680

FDA Product Code LFT: Fluorescent Immunoassay, Primidone

Leading manufacturers include Roche Diagnostic Systems, Inc., Baxter Healthcare 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 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 Jan 07, 1983
ADVANCE EMIT-AED PRIMEDONE ASSAY
K823741
Syva Co.
Chemistry · 25d

About Product Code LFT - Regulatory Context