JFJ · Class II · 21 CFR 862.1070

FDA Product Code JFJ: Catalytic Methods, Amylase

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

99
Total
99
Cleared
83d
Avg days
1977
Since
99 devices
73–96 of 99
Cleared Sep 29, 1986
AMYLASE SR LIQUID STABLE REAGENT SET
K862733
Medical Analysis Systems, Inc.
Chemistry · 73d
Cleared Sep 29, 1986
AMYLASE PROCEDURE
K863588
Data Medical Associates, Inc.
Chemistry · 14d
Cleared May 29, 1986
RAICHEM AMYLASE REAGENT
K861269
Reagents Applications, Inc.
Chemistry · 55d
Cleared May 29, 1986
AMYLASE REAGENT CATALOGUE NOS. 85108 AND 85109
K861718
Reagents Applications, Inc.
Chemistry · 28d
Cleared Apr 07, 1986
ALPHA-AMYLASE TEST
K860665
Sclavo, Inc.
Chemistry · 42d
Cleared Apr 03, 1986
EASY-TEST AMLASE (AMYL), #67521/93
K860918
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Mar 14, 1986
ENZYMATIC ALPHA-AMYLASE REAGENT KIT
K860245
Bio-Analytics Laboratories, Inc.
Chemistry · 49d
Cleared Jun 10, 1985
AMY REAGENT
K852001
Alpkem Corp.
Chemistry · 34d
Cleared Mar 14, 1985
AMYLASE PRODUCTS
K850798
Data Medical Associates, Inc.
Chemistry · 15d
Cleared Nov 25, 1983
AMYLASE
K832889
Pointe Scientific, Inc.,
Chemistry · 95d
Cleared Jul 07, 1983
AMYLAST-D TEST
K831561
Sclavo, Inc.
Chemistry · 52d
Cleared Jun 17, 1983
PARAMAX AMALINE REAGENT
K831536
American Dade
Chemistry · 39d
Cleared Dec 28, 1982
SINGLE VIAL AMYLASE PNP TEST
K823462
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Jul 13, 1982
ULTRAZYME PLUS AMYL
K821869
Harleco Diagnostics
Chemistry · 18d
Cleared May 28, 1982
ULTRAZYME PLUS AMYL #65031&64982
K821459
Emd Chemicals, Inc.
Chemistry · 10d
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 Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL
K772035
Harleco
Chemistry · 21d
Cleared Sep 13, 1977
MULTISTAT III, AMYLASE TEST
K771622
Instrumentation Laboratory CO
Chemistry · 19d
Cleared Sep 02, 1977
AMYLASE ULTRAZYME PLUS
K771388
Harleco
Chemistry · 37d
Cleared Jul 21, 1977
CLINICARD UV AMYLASE CHEMISTRY
K771131
Harleco
Chemistry · 28d
Cleared Jul 05, 1977
REAGENT KIT, ENZYMATIC AMYLASE
K770750
Beckman Instruments, Inc.
Chemistry · 71d