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
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 Nov 17, 2008
EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
K080823
Medica Corp.
Chemistry · 238d
Cleared May 22, 2007
AMYLASE EPS REAGENT
K070064
Thermo Fisher Scientific
Chemistry · 137d
Cleared May 10, 2004
AMYLASE LIQUID REAGENT, MODEL A532-200
K040920
Teco Diagnostics
Chemistry · 32d
Cleared Mar 11, 2004
VITALAB AMYLASE REAGENT
K040534
Clinical Data, Inc.
Chemistry · 9d
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 Jun 26, 2000
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
K001569
Sigma Diagnostics, Inc.
Chemistry · 38d
Cleared Jan 13, 1999
WAKO L-TYPE AMYLASE
K984184
Wako Chemicals USA, Inc.
Chemistry · 51d
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 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 Feb 08, 1995
CATALOGUE NUMBER 321-07/15/50
K945243
Diagnostic Chemicals , Ltd.
Chemistry · 104d
Cleared Dec 09, 1994
OLYMPUS AMYLASE REAGENT
K944229
Olympus America, Inc.
Chemistry · 100d
Cleared May 03, 1994
SYNERMED AMYLASE REAGENT KIT
K941091
Synermed, Inc.
Chemistry · 56d
Cleared Nov 05, 1993
AMYLASE REAGENT SET (KINETIC)
K931080
Teco Diagnostics
Chemistry · 248d
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

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.