LCY · Class II · 21 CFR 862.3880

FDA Product Code LCY: U.v. Spectrometry, Theophylline

Leading manufacturers include Syva Co. and Gds Diagnostics.

3
Total
3
Cleared
33d
Avg days
1978
Since

FDA 510(k) Cleared U.v. Spectrometry, Theophylline Devices (Product Code LCY)

3 devices
1–3 of 3
Cleared May 16, 1989
GDS ENZYMATIC THEOPHYLLINE REAGENT
K891761
Gds Diagnostics
Chemistry · 53d
Cleared Apr 12, 1978
THEOPHYLLINE ASSAY TO THE CENTRIFICHEM
K780441
Syva Co.
Immunology · 23d
Cleared Apr 12, 1978
THEOPHYLLINE ASSAY TO THE GEMSAEC
K780442
Syva Co.
Immunology · 23d

About Product Code LCY - Regulatory Context