CIJ · Class II · 21 CFR 862.1070

FDA Product Code CIJ: Saccharogenic, Amylase

Leading manufacturers include Harleco, Coulter Electronics, Inc. and Em Diagnostic Systems, Inc..

31
Total
31
Cleared
84d
Avg days
1976
Since
31 devices
25–31 of 31
Cleared Dec 27, 1979
CHEM-STRATE AMYLASE
K792479
General Diagnostics
Chemistry · 24d
Cleared May 19, 1978
ULTRA ZYME PLUS AMYL 64982, GILFORD 3500
K780513
Harleco
Chemistry · 50d
Cleared Mar 09, 1978
ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI.
K780141
Harleco
Chemistry · 42d
Cleared Nov 05, 1976
ENZYMATIC AMYLASE REAGENT KIT
K760415
Beckman Instruments, Inc.
Chemistry · 88d
Cleared Sep 21, 1976
ULTRAZYME AMYLASE
K760026
Harleco
Chemistry · 99d