Product code JFJ
- Device name
- Catalytic Methods, Amylase
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1070
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K210633 | Amylase2 | Abbott Ireland Diagnostics Division | 2022-05-26 |
| K191454 | Atellica CH Amylase_2 (AMY_2) | Siemens Healthcare Diagnostics, Inc. | 2019-07-30 |
| K182474 | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL | Biosystems S.A. | 2019-05-02 |
| K130685 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY | Hitachi Chemical Diagnostics, Inc. | 2013-08-09 |
| K122858 | ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II | Elitechgroup | 2012-10-03 |
| K091846 | SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 | Beckman Coulter, Inc. | 2009-10-16 |
| K080823 | EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT | Medica Corp. | 2008-11-17 |
| K070064 | AMYLASE EPS REAGENT | Thermo Fisher Scientific | 2007-05-22 |
| K062180 | ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP | Horiba Abx | 2006-10-02 |
| K051447 | SENTINEL PANCREATIC AMYLASE | Sentinel Ch. Srl | 2006-01-26 |
| K040920 | AMYLASE LIQUID REAGENT, MODEL A532-200 | Teco Diagnostics | 2004-05-10 |
| K040534 | VITALAB AMYLASE REAGENT | Clinical Data, Inc. | 2004-03-11 |
| K023549 | WIENER LAB AMILASA 405 AA LIQUIDA | Wiener Laboratories Saic | 2002-12-09 |
| K020282 | JAS AMYLASE LIQUID REAGENT | Jas Diagnostics, Inc. | 2002-02-28 |
| K013978 | SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT | Beckman Coulter, Inc. | 2002-01-15 |
| K013101 | WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA | Wiener Laboratories Saic | 2001-11-16 |
| K011843 | GENZYME DIRECT-AMYLASE TEST REAGENT | Genzyme Corp. | 2001-08-10 |
| K011145 | MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 | Roche Diagnostics Corp. | 2001-06-25 |
| K001569 | INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) | Sigma Diagnostics, Inc. | 2000-06-26 |
| K990025 | CARESIDE AMYLASE | Careside, Inc. | 1999-02-08 |
| K984184 | WAKO L-TYPE AMYLASE | Wako Chemicals USA, Inc. | 1999-01-13 |
| K981653 | AMY | Abbott Laboratories | 1998-08-28 |
| K981216 | AMY | Abbott Laboratories | 1998-06-08 |
| K974125 | IL TEST AMYLASE | Instrumentation Laboratory CO | 1997-12-17 |
| K974053 | AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 | Diagnostic Chemicals , Ltd. | 1997-12-08 |
| K972250 | ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS | Roche Diagnostic Systems, Inc. | 1997-08-12 |
| K971825 | PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST | Randox Laboratories, Ltd. | 1997-07-24 |
| K972297 | AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Trace America, Inc. | 1997-07-17 |
| K951548 | ACE AMYLASE REAGENT | Schiapparelli Biosystems, Inc. | 1995-05-15 |
| K945243 | CATALOGUE NUMBER 321-07/15/50 | Diagnostic Chemicals , Ltd. | 1995-02-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380740155612 | Alinity | ABBOTT IRELAND | 2025-12-19 |
| 00380740156718 | ARCHITECT | ABBOTT IRELAND | 2025-12-19 |
| 10673486001129 | α – AMYLASE LIQUID REAGENT (KINETIC METHOD) | TECO DIAGNOSTICS | 2023-07-20 |
| 10673486001136 | α – AMYLASE LIQUID REAGENT (KINETIC METHOD) TC MATRIX-240/480 | TECO DIAGNOSTICS | 2023-07-20 |
| 10673486001143 | AMYLASE REAGENT SET (KINETIC METHOD) | TECO DIAGNOSTICS | 2023-07-20 |
| 03610230006849 | Yumizen C1200 Amylase | HORIBA ABX SAS | 2020-08-31 |
| 07613336121016 | a-Amylase EPS Pancreatic | Roche Diagnostics GmbH | 2020-03-05 |
| 07613336121009 | a-Amylase EPS ver.2 | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740161668 | ARCHITECT | Abbott GmbH | 2019-11-15 |
| 00630414238357 | Atellica CH AMY_2 | Siemens Healthcare Diagnostics Inc. | 2019-09-03 |
| 00386100002138 | AMY Reagent Kit | MEDICA CORPORATION | 2019-02-14 |
| 05060500091705 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2017-02-28 |
| 04015630926886 | alpha-Amylase EPS ver.2 | Roche Diagnostics GmbH | 2016-09-20 |
| 05060500090166 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2016-09-20 |
| 05060500090159 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2016-09-20 |
| 05060500090142 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2016-09-20 |
| 05060500090135 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2016-09-20 |
| 05060500090128 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2016-09-20 |
| 04015630918935 | Amylase EPS ver2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630913893 | AMYP Amylase EPS Pancreatic | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630924875 | alpha-Amylase EPS ver.2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630924882 | alpha-Amylase EPS Pancreatic | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630926848 | alpha-Amylase EPS Pancreatic | Roche Diagnostics GmbH | 2016-09-20 |
| 05055273200591 | P AMY | RANDOX LABORATORIES LIMITED | 2016-09-09 |
| 05055273200614 | P AMY | RANDOX LABORATORIES LIMITED | 2016-09-09 |
| 05055273200669 | P AMY | RANDOX LABORATORIES LIMITED | 2016-09-09 |
| 15099590206345 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590224448 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 03610230004913 | ABX PENTRA AMYLASE CP | HORIBA ABX SAS | 2016-08-23 |
| 08058056680587 | Pancreatic Amylase | SENTINEL CH. SPA | 2016-06-29 |