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
49–72 of 99
Cleared Apr 30, 1991
AMYLASE
K910158
Pointe Scientific, Inc.,
Chemistry · 105d
Cleared Jan 31, 1991
KINETIC AMYLASE DETERMINATION
K905651
Biochemical Trade, Inc.
Chemistry · 44d
Cleared Sep 07, 1990
ROCHE COBAS READY AMYLASE REAGENT
K903309
Roche Diagnostic Systems, Inc.
Chemistry · 45d
Cleared Aug 17, 1990
SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404
K903332
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Jul 31, 1990
AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS
K902326
Catachem, Inc.
Chemistry · 68d
Cleared May 15, 1990
DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI
K901017
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 71d
Cleared Apr 03, 1990
COULTER AMYLASE REAGENT
K900230
Coulter Corp.
Chemistry · 76d
Cleared Feb 08, 1990
AMYLASE REAGENT
K896650
Sigma Chemical Co.
Chemistry · 76d
Cleared Aug 17, 1989
AMYLASE TEST (AML) ITEM NUMBER: 65404
K893751
Em Diagnostic Systems, Inc.
Chemistry · 90d
Cleared Aug 15, 1989
ABBOTT SPECTRUM AMYLASE REAGENT
K891241
Abbott Laboratories
Chemistry · 161d
Cleared Jul 20, 1989
PANCREATIC A-AMYLASE PNP
K892848
Boehringer Mannheim Corp.
Chemistry · 93d
Cleared Feb 17, 1989
AMYLASE SR LIQUID STABLE REAGENT SET
K885176
Medical Analysis Systems, Inc.
Chemistry · 65d
Cleared Apr 19, 1988
AMYLASE 405 CATALOG NUMBER 301-34
K880867
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 49d
Cleared Jan 05, 1988
REFLOTRON (R) AMYLASE
K874704
Boehringer Mannheim Corp.
Chemistry · 47d
Cleared Nov 23, 1987
A-GENT LIQUID AMYLASE
K873944
Abbott Laboratories
Chemistry · 56d
Cleared Oct 06, 1987
BNP-AMYLASE TEST
K873133
Sclavo, Inc.
Chemistry · 57d
Cleared Aug 05, 1987
AMYLASE TEST KIT
K872023
Ciba Corning Diagnostics Corp.
Chemistry · 71d
Cleared Jun 01, 1987
STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715
K870746
Stanbio Laboratory
Chemistry · 96d
Cleared Apr 13, 1987
RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C)
K871269
Technicon Instruments Corp.
Chemistry · 13d
Cleared Feb 20, 1987
AMYLASE COLORIMETRIC PROCEDURE
K864825
Data Medical Associates, Inc.
Chemistry · 73d
Cleared Jan 21, 1987
PSI AMYLASE REAGENT
K864464
Pointe Scientific, Inc.,
Chemistry · 70d
Cleared Dec 31, 1986
QKO (TM) AMYLASE B-HA
K864303
Wako Chemicals USA, Inc.
Chemistry · 61d
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