FDA 510(k) Applications for Medical Device Product Code "JFJ"
(Catalytic Methods, Amylase)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K210633 | Abbott Ireland Diagnostics Division | Amylase2 | 05/26/2022 |
| K981216 | ABBOTT LABORATORIES | AMY | 06/08/1998 |
| K981653 | ABBOTT LABORATORIES | AMY | 08/28/1998 |
| K013978 | BECKMAN COULTER, INC. | SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT | 01/15/2002 |
| K091846 | BECKMAN COULTER, INC. | SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 | 10/16/2009 |
| K182474 | BioSystems S.A. | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL | 05/02/2019 |
| K990025 | CARESIDE, INC. | CARESIDE AMYLASE | 02/08/1999 |
| K040534 | CLINICAL DATA, INC. | VITALAB AMYLASE REAGENT | 03/11/2004 |
| K974053 | DIAGNOSTIC CHEMICALS LTD. | AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 | 12/08/1997 |
| K122858 | ELITECHGROUP | ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II | 10/03/2012 |
| K011843 | GENZYME CORP. | GENZYME DIRECT-AMYLASE TEST REAGENT | 08/10/2001 |
| K130685 | HITACHI CHEMICAL DIAGNOSTICS, INC. | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY | 08/09/2013 |
| K062180 | HORIBA ABX | ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP | 10/02/2006 |
| K974125 | INSTRUMENTATION LABORATORY CO. | IL TEST AMYLASE | 12/17/1997 |
| K020282 | JAS Diagnostics, Inc. | JAS AMYLASE LIQUID REAGENT | 02/28/2002 |
| K080823 | MEDICA CORP. | EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT | 11/17/2008 |
| K971825 | RANDOX LABORATORIES, LTD. | PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST | 07/24/1997 |
| K972250 | ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS | 08/12/1997 |
| K011145 | ROCHE DIAGNOSTICS CORP. | MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 | 06/25/2001 |
| K051447 | SENTINEL CH. SRL | SENTINEL PANCREATIC AMYLASE | 01/26/2006 |
| K191454 | Siemens Healthcare Diagnostics Inc. | Atellica CH Amylase_2 (AMY_2) | 07/30/2019 |
| K001569 | SIGMA DIAGNOSTICS, INC. | INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) | 06/26/2000 |
| K040920 | TECO DIAGNOSTICS | AMYLASE LIQUID REAGENT, MODEL A532-200 | 05/10/2004 |
| K070064 | Thermo Fisher Scientific | AMYLASE EPS REAGENT | 05/22/2007 |
| K972297 | TRACE AMERICA, INC. | AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | 07/17/1997 |
| K984184 | WAKO CHEMICALS, USA, INC. | WAKO L-TYPE AMYLASE | 01/13/1999 |
| K023549 | WIENER LABORATORIES S.A.I.C. | WIENER LAB AMILASA 405 AA LIQUIDA | 12/09/2002 |
| K013101 | WIENER LABORATORIES S.A.I.C. | WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA | 11/16/2001 |
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