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
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 Aug 09, 2013
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
K130685
Hitachi Chemical Diagnostics, Inc.
Chemistry · 149d
Cleared Oct 03, 2012
ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
K122858
Elitechgroup
Chemistry · 15d
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 Oct 02, 2006
ABX PENTRA AMYLASE CP
K062180
Horiba Abx
Chemistry · 63d
Cleared Jan 26, 2006
SENTINEL PANCREATIC AMYLASE
K051447
Sentinel Ch. Srl
Chemistry · 238d
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 Dec 09, 2002
WIENER LAB AMILASA 405 AA LIQUIDA
K023549
Wiener Laboratories Saic
Chemistry · 48d
Cleared Feb 28, 2002
JAS AMYLASE LIQUID REAGENT
K020282
Jas Diagnostics, Inc.
Chemistry · 31d
Cleared Jan 15, 2002
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
K013978
Beckman Coulter, Inc.
Chemistry · 43d
Cleared Nov 16, 2001
WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA
K013101
Wiener Laboratories Saic
Chemistry · 60d
Cleared Aug 10, 2001
GENZYME DIRECT-AMYLASE TEST REAGENT
K011843
Genzyme Corp.
Chemistry · 59d
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 Feb 08, 1999
CARESIDE AMYLASE
K990025
Careside, Inc.
Chemistry · 35d
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

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.