JFJ · Class II · 21 CFR 862.1070

FDA Product Code JFJ: Catalytic Methods, Amylase

Leading manufacturers include Em Diagnostic Systems, Inc., Abbott Laboratories and Pointe Scientific, Inc.,.

99
Total
99
Cleared
83d
Avg days
1977
Since
99 devices
25–48 of 99
Cleared Dec 08, 1997
AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10
K974053
Diagnostic Chemicals , Ltd.
Chemistry · 42d
Cleared Aug 12, 1997
ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
K972250
Roche Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Jul 24, 1997
PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST
K971825
Randox Laboratories, Ltd.
Chemistry · 69d
Cleared Jul 17, 1997
AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K972297
Trace America, Inc.
Chemistry · 28d
Cleared May 15, 1995
ACE AMYLASE REAGENT
K951548
Schiapparelli Biosystems, Inc.
Chemistry · 41d
Cleared Feb 08, 1995
CATALOGUE NUMBER 321-07/15/50
K945243
Diagnostic Chemicals , Ltd.
Chemistry · 104d
Cleared Dec 09, 1994
AMYLASE QVET
K942961
Prisma Systems
Chemistry · 169d
Cleared Dec 09, 1994
OLYMPUS AMYLASE REAGENT
K944229
Olympus America, Inc.
Chemistry · 100d
Cleared Sep 09, 1994
DUPONT DIMENSION AMYLASE METHOD
K942640
Dupont Medical Products
Chemistry · 98d
Cleared May 03, 1994
SYNERMED AMYLASE REAGENT KIT
K941091
Synermed, Inc.
Chemistry · 56d
Cleared Jan 31, 1994
INTERSECT SYSTEMS DIRECT AMYLASE REAGENT
K932888
Intersect Systems, Inc.
Chemistry · 231d
Cleared Nov 05, 1993
AMYLASE REAGENT SET (KINETIC)
K931080
Teco Diagnostics
Chemistry · 248d
Cleared Oct 28, 1993
GENZYME A-AMYLASE TEST REAGENT
K933397
Genzyme Corp.
Chemistry · 108d
Cleared Aug 19, 1993
ETHYLIDENE AMYL
K931582
Em Diagnostic Systems, Inc.
Chemistry · 141d
Cleared Aug 19, 1993
SILYL AMYL
K931583
Em Diagnostic Systems, Inc.
Chemistry · 141d
Cleared Jul 19, 1993
LIQUID AMYLASE REAGENT SET
K930475
Pointe Scientific, Inc.,
Chemistry · 172d
Cleared Oct 02, 1992
OLYMPUS AMYLASE REAGENT
K923346
Olympus Corp.
Chemistry · 94d
Cleared Sep 28, 1992
MILES URINE AMYLASE METHOD
K923105
Heraeus Kulzer, Inc.
Chemistry · 101d
Cleared Sep 09, 1992
AMYLASE TEST
K923677
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Mar 27, 1992
AMYLASE REAGENT
K921057
Genzyme Corp.
Chemistry · 22d
Cleared Mar 02, 1992
ABBOTT QUICKSTART AMYLASE, #5AXX
K920583
Em Diagnostic Systems, Inc.
Chemistry · 21d
Cleared Feb 18, 1992
IL TEST(TM) AMLYLASE
K913744
Instrumentation Laboratory CO
Chemistry · 182d
Cleared Sep 11, 1991
AMYLASE REAGENT (PROCEDURE 577)
K913858
Sigma Diagnostics, Inc.
Chemistry · 15d
Cleared Jul 01, 1991
AMYLASE REAGENT
K912519
Genzyme Corp.
Chemistry · 25d