JFJ · Class II · 21 CFR 862.1070

FDA Product Code JFJ: Catalytic Methods, Amylase

Leading manufacturers include Em Diagnostic Systems, Inc., Abbott Laboratories and Boehringer Mannheim Corp..

99
Total
99
Cleared
83d
Avg days
1977
Since
99 devices
25–48 of 99
Cleared Dec 16, 1986
VISION(TM) AMYLASE
K864435
Abbott Laboratories
Chemistry · 34d
Cleared Oct 03, 1986
TDX(R) AMYLASE II
K863622
Abbott Laboratories
Chemistry · 17d
Cleared Apr 03, 1986
EASY-TEST AMLASE (AMYL), #67521/93
K860918
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Dec 28, 1982
SINGLE VIAL AMYLASE PNP TEST
K823462
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Nov 12, 1980
BEKCMAN ASTRA SYSTEMS AMYLASE CHEMISTRY
K802581
Beckman Instruments, Inc.
Chemistry · 23d
Cleared Jan 23, 1980
DELTA TEST AMYLASE UV
K800049
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 14d
Cleared Sep 13, 1977
MULTISTAT III, AMYLASE TEST
K771622
Instrumentation Laboratory CO
Chemistry · 19d
Cleared Jul 05, 1977
REAGENT KIT, ENZYMATIC AMYLASE
K770750
Beckman Instruments, Inc.
Chemistry · 71d