JFJ · Class II · 21 CFR 862.1070

FDA Product Code JFJ: Catalytic Methods, Amylase

Leading manufacturers include Em Diagnostic Systems, Inc., Abbott Laboratories and Instrumentation Laboratory CO.

99
Total
99
Cleared
83d
Avg days
1977
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Catalytic Methods, Amylase Devices (Product Code JFJ)

99 devices
1–24 of 99
Cleared May 26, 2022
Amylase2
K210633
Abbott Ireland Diagnostics Division
Chemistry · 449d
Cleared Jul 30, 2019
Atellica CH Amylase_2 (AMY_2)
K191454
Siemens Healthcare Diagnostics, Inc.
Chemistry · 60d
Cleared May 02, 2019
alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
K182474
Biosystems S.A.
Chemistry · 234d
Cleared Oct 16, 2009
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
K091846
Beckman Coulter, Inc.
Chemistry · 116d
Cleared Jan 15, 2002
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
K013978
Beckman Coulter, Inc.
Chemistry · 43d
Cleared Jun 25, 2001
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
K011145
Roche Diagnostics Corp.
Chemistry · 91d
Cleared Aug 28, 1998
AMY
K981653
Abbott Laboratories
Chemistry · 109d
Cleared Jun 08, 1998
AMY
K981216
Abbott Laboratories
Chemistry · 66d
Cleared Dec 17, 1997
IL TEST AMYLASE
K974125
Instrumentation Laboratory CO
Chemistry · 44d
Cleared Aug 12, 1997
ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
K972250
Roche Diagnostic Systems, Inc.
Chemistry · 57d
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 Sep 09, 1992
AMYLASE TEST
K923677
Em Diagnostic Systems, Inc.
Chemistry · 49d
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 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 May 15, 1990
DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI
K901017
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 71d
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 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

About Product Code JFJ - Regulatory Context

510(k) Submission Activity

99 total 510(k) submissions under product code JFJ since 1977, with 99 receiving FDA clearance (average review time: 83 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.