FDA Product Code CIJ: Saccharogenic, Amylase
Leading manufacturers include Em Diagnostic Systems, Inc., Beckman Instruments, Inc. and Roche Diagnostic Systems, Inc..
31
Total
31
Cleared
84d
Avg days
1976
Since
FDA 510(k) Cleared Saccharogenic, Amylase Devices (Product Code CIJ)
31 devices
Cleared
Jan 03, 1989
-AMYLASE EPS
Boehringer Mannheim Corp.
Chemistry
222d
Cleared
Oct 20, 1987
ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL
Roche Diagnostic Systems, Inc.
Chemistry
64d
Cleared
Oct 20, 1987
IL 35260, IL TEST AMYLASE REAGENT
Instrumentation Laboratory CO
Chemistry
48d
Cleared
May 23, 1986
EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95
Em Diagnostic Systems, Inc.
Chemistry
72d
Cleared
Sep 28, 1984
SYSTEMATE A AMYLASE HEM 67204
Em Diagnostic Systems, Inc.
Chemistry
11d
Cleared
Nov 05, 1976
ENZYMATIC AMYLASE REAGENT KIT
Beckman Instruments, Inc.
Chemistry
88d