FDA Product Code
FDA Product Code JFJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1070
510(k) Clearances — 99 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K210633 | Amylase2 | Abbott Ireland Diagnostics Division | 2022-05-26 | Traditional | PDF ↗ |
| K191454 | Atellica CH Amylase_2 (AMY_2) | Siemens Healthcare Diagnostics, Inc. | 2019-07-30 | Traditional | PDF ↗ |
| K182474 | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL | Biosystems S.A. | 2019-05-02 | Traditional | PDF ↗ |
| K130685 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY | Hitachi Chemical Diagnostics, Inc. | 2013-08-09 | Traditional | PDF ↗ |
| K122858 | ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II | Elitechgroup | 2012-10-03 | Traditional | PDF ↗ |
| K091846 | SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 | Beckman Coulter, Inc. | 2009-10-16 | Traditional | PDF ↗ |
| K080823 | EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT | Medica Corp. | 2008-11-17 | Traditional | PDF ↗ |
| K070064 | AMYLASE EPS REAGENT | Thermo Fisher Scientific | 2007-05-22 | Traditional | PDF ↗ |
| K062180 | ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP | Horiba Abx | 2006-10-02 | Traditional | PDF ↗ |
| K051447 | SENTINEL PANCREATIC AMYLASE | Sentinel Ch. Srl | 2006-01-26 | Traditional | PDF ↗ |
| K040920 | AMYLASE LIQUID REAGENT, MODEL A532-200 | Teco Diagnostics | 2004-05-10 | Special | PDF ↗ |
| K040534 | VITALAB AMYLASE REAGENT | Clinical Data, Inc. | 2004-03-11 | Traditional | PDF ↗ |
| K023549 | WIENER LAB AMILASA 405 AA LIQUIDA | Wiener Laboratories Saic | 2002-12-09 | Traditional | PDF ↗ |
| K020282 | JAS AMYLASE LIQUID REAGENT | Jas Diagnostics, Inc. | 2002-02-28 | Traditional | PDF ↗ |
| K013978 | SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT | Beckman Coulter, Inc. | 2002-01-15 | Traditional | PDF ↗ |
| K013101 | WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA | Wiener Laboratories Saic | 2001-11-16 | Traditional | PDF ↗ |
| K011843 | GENZYME DIRECT-AMYLASE TEST REAGENT | Genzyme Corp. | 2001-08-10 | Traditional | PDF ↗ |
| K011145 | MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 | Roche Diagnostics Corp. | 2001-06-25 | Traditional | PDF ↗ |
| K001569 | INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) | Sigma Diagnostics, Inc. | 2000-06-26 | Traditional | PDF ↗ |
| K990025 | CARESIDE AMYLASE | Careside, Inc. | 1999-02-08 | Traditional | PDF ↗ |
| K984184 | WAKO L-TYPE AMYLASE | Wako Chemicals USA, Inc. | 1999-01-13 | Traditional | PDF ↗ |
| K981653 | AMY | Abbott Laboratories | 1998-08-28 | Traditional | PDF ↗ |
| K981216 | AMY | Abbott Laboratories | 1998-06-08 | Traditional | PDF ↗ |
| K974125 | IL TEST AMYLASE | Instrumentation Laboratory CO | 1997-12-17 | Traditional | PDF ↗ |
| K974053 | AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 | Diagnostic Chemicals , Ltd. | 1997-12-08 | Traditional | PDF ↗ |
| K972250 | ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS | Roche Diagnostic Systems, Inc. | 1997-08-12 | Traditional | PDF ↗ |
| K971825 | PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST | Randox Laboratories, Ltd. | 1997-07-24 | Traditional | PDF ↗ |
| K972297 | AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Trace America, Inc. | 1997-07-17 | Traditional | PDF ↗ |
| K951548 | ACE AMYLASE REAGENT | Schiapparelli Biosystems, Inc. | 1995-05-15 | Traditional | PDF ↗ |
| K945243 | CATALOGUE NUMBER 321-07/15/50 | Diagnostic Chemicals , Ltd. | 1995-02-08 | Traditional | PDF ↗ |
| K942961 | AMYLASE QVET | Prisma Systems | 1994-12-09 | Traditional | PDF ↗ |
| K944229 | OLYMPUS AMYLASE REAGENT | Olympus America, Inc. | 1994-12-09 | Traditional | PDF ↗ |
| K942640 | DUPONT DIMENSION AMYLASE METHOD | Dupont Medical Products | 1994-09-09 | Traditional | PDF ↗ |
| K934293 | BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT | Beckman-Diagnostic Systems Group | 1994-07-06 | Traditional | PDF ↗ |
| K941091 | SYNERMED AMYLASE REAGENT KIT | Synermed, Inc. | 1994-05-03 | Traditional | PDF ↗ |
| K933682 | DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS | Miles, Inc. | 1994-04-12 | Traditional | PDF ↗ |
| K930678 | AMYLASE | Horizon Diagnostics, Inc. | 1994-04-06 | Traditional | PDF ↗ |
| K932888 | INTERSECT SYSTEMS DIRECT AMYLASE REAGENT | Intersect Systems, Inc. | 1994-01-31 | Traditional | PDF ↗ |
| K931080 | AMYLASE REAGENT SET (KINETIC) | Teco Diagnostics | 1993-11-05 | Traditional | PDF ↗ |
| K933397 | GENZYME A-AMYLASE TEST REAGENT | Genzyme Corp. | 1993-10-28 | Traditional | PDF ↗ |
| K931583 | SILYL AMYL | Em Diagnostic Systems, Inc. | 1993-08-19 | Traditional | PDF ↗ |
| K931582 | ETHYLIDENE AMYL | Em Diagnostic Systems, Inc. | 1993-08-19 | Traditional | PDF ↗ |
| K930475 | LIQUID AMYLASE REAGENT SET | Pointe Scientific, Inc., | 1993-07-19 | Traditional | PDF ↗ |
| K923346 | OLYMPUS AMYLASE REAGENT | Olympus Corp. | 1992-10-02 | Traditional | PDF ↗ |
| K923105 | MILES URINE AMYLASE METHOD | Heraeus Kulzer, Inc. | 1992-09-28 | Traditional | PDF ↗ |
| K923677 | AMYLASE TEST | Em Diagnostic Systems, Inc. | 1992-09-09 | Traditional | PDF ↗ |
| K921057 | AMYLASE REAGENT | Genzyme Corp. | 1992-03-27 | Traditional | PDF ↗ |
| K920583 | ABBOTT QUICKSTART AMYLASE, #5AXX | Em Diagnostic Systems, Inc. | 1992-03-02 | Traditional | PDF ↗ |
| K913744 | IL TEST(TM) AMLYLASE | Instrumentation Laboratory CO | 1992-02-18 | Traditional | PDF ↗ |
| K915710 | AMYLASE (COLORIMETRIC) REAGENT SET | Tech Intl. Co. | 1992-01-30 | Traditional | PDF ↗ |
| K913858 | AMYLASE REAGENT (PROCEDURE 577) | Sigma Diagnostics, Inc. | 1991-09-11 | Traditional | PDF ↗ |
| K912519 | AMYLASE REAGENT | Genzyme Corp. | 1991-07-01 | Traditional | PDF ↗ |
| K910158 | AMYLASE | Pointe Scientific, Inc., | 1991-04-30 | Traditional | PDF ↗ |
| K905651 | KINETIC AMYLASE DETERMINATION | Biochemical Trade, Inc. | 1991-01-31 | Traditional | PDF ↗ |
| K903309 | ROCHE COBAS READY AMYLASE REAGENT | Roche Diagnostic Systems, Inc. | 1990-09-07 | Traditional | PDF ↗ |
| K903332 | SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404 | Em Diagnostic Systems, Inc. | 1990-08-17 | Traditional | PDF ↗ |
| K902326 | AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS | Catachem, Inc. | 1990-07-31 | Traditional | PDF ↗ |
| K901017 | DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI | E.I. Dupont DE Nemours & Co., Inc. | 1990-05-15 | Traditional | PDF ↗ |
| K900230 | COULTER AMYLASE REAGENT | Coulter Corp. | 1990-04-03 | Traditional | PDF ↗ |
| K896650 | AMYLASE REAGENT | Sigma Chemical Co. | 1990-02-08 | Traditional | PDF ↗ |
| K893751 | AMYLASE TEST (AML) ITEM NUMBER: 65404 | Em Diagnostic Systems, Inc. | 1989-08-17 | Traditional | PDF ↗ |
| K891241 | ABBOTT SPECTRUM AMYLASE REAGENT | Abbott Laboratories | 1989-08-15 | Traditional | PDF ↗ |
| K892848 | PANCREATIC A-AMYLASE PNP | Boehringer Mannheim Corp. | 1989-07-20 | Traditional | PDF ↗ |
| K885176 | AMYLASE SR LIQUID STABLE REAGENT SET | Medical Analysis Systems, Inc. | 1989-02-17 | Traditional | PDF ↗ |
| K880867 | AMYLASE 405 CATALOG NUMBER 301-34 | Diagnostic Chemicals, Ltd. (Usa) | 1988-04-19 | Traditional | PDF ↗ |
| K874704 | REFLOTRON (R) AMYLASE | Boehringer Mannheim Corp. | 1988-01-05 | Traditional | PDF ↗ |
| K873944 | A-GENT LIQUID AMYLASE | Abbott Laboratories | 1987-11-23 | Traditional | PDF ↗ |
| K873133 | BNP-AMYLASE TEST | Sclavo, Inc. | 1987-10-06 | Traditional | PDF ↗ |
| K872023 | AMYLASE TEST KIT | Ciba Corning Diagnostics Corp. | 1987-08-05 | Traditional | PDF ↗ |
| K870746 | STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715 | Stanbio Laboratory | 1987-06-01 | Traditional | PDF ↗ |
| K871269 | RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C) | Technicon Instruments Corp. | 1987-04-13 | Traditional | PDF ↗ |
| K864825 | AMYLASE COLORIMETRIC PROCEDURE | Data Medical Associates, Inc. | 1987-02-20 | Traditional | PDF ↗ |
| K864464 | PSI AMYLASE REAGENT | Pointe Scientific, Inc., | 1987-01-21 | Traditional | PDF ↗ |
| K864303 | QKO (TM) AMYLASE B-HA | Wako Chemicals USA, Inc. | 1986-12-31 | Traditional | PDF ↗ |
| K864435 | VISION(TM) AMYLASE | Abbott Laboratories | 1986-12-16 | Traditional | PDF ↗ |
| K863622 | TDX(R) AMYLASE II | Abbott Laboratories | 1986-10-03 | Traditional | PDF ↗ |
| K863588 | AMYLASE PROCEDURE | Data Medical Associates, Inc. | 1986-09-29 | Traditional | PDF ↗ |
| K862733 | AMYLASE SR LIQUID STABLE REAGENT SET | Medical Analysis Systems, Inc. | 1986-09-29 | Traditional | PDF ↗ |
| K861269 | RAICHEM AMYLASE REAGENT | Reagents Applications, Inc. | 1986-05-29 | Traditional | PDF ↗ |
| K861718 | AMYLASE REAGENT CATALOGUE NOS. 85108 AND 85109 | Reagents Applications, Inc. | 1986-05-29 | Traditional | PDF ↗ |
| K860665 | ALPHA-AMYLASE TEST | Sclavo, Inc. | 1986-04-07 | Traditional | PDF ↗ |
| K860918 | EASY-TEST AMLASE (AMYL), #67521/93 | Em Diagnostic Systems, Inc. | 1986-04-03 | Traditional | PDF ↗ |
| K860245 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | Bio-Analytics Laboratories, Inc. | 1986-03-14 | Traditional | PDF ↗ |
| K852001 | AMY REAGENT | Alpkem Corp. | 1985-06-10 | Traditional | PDF ↗ |
| K850798 | AMYLASE PRODUCTS | Data Medical Associates, Inc. | 1985-03-14 | Traditional | PDF ↗ |
| K832889 | AMYLASE | Pointe Scientific, Inc., | 1983-11-25 | Traditional | PDF ↗ |
| K831561 | AMYLAST-D TEST | Sclavo, Inc. | 1983-07-07 | Traditional | PDF ↗ |
| K831536 | PARAMAX AMALINE REAGENT | American Dade | 1983-06-17 | Traditional | PDF ↗ |
| K823462 | SINGLE VIAL AMYLASE PNP TEST | Boehringer Mannheim Corp. | 1982-12-28 | Traditional | PDF ↗ |
| K821869 | ULTRAZYME PLUS AMYL | Harleco Diagnostics | 1982-07-13 | Traditional | PDF ↗ |
| K821459 | ULTRAZYME PLUS AMYL #65031&64982 | Emd Chemicals, Inc. | 1982-05-28 | Traditional | PDF ↗ |
| K802581 | BEKCMAN ASTRA SYSTEMS AMYLASE CHEMISTRY | Beckman Instruments, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K801295 | COBAS REAGENT FOR A-AMYLASE | Roche Analytical Instruments, Inc. | 1980-07-08 | Traditional | PDF ↗ |
| K800049 | DELTA TEST AMYLASE UV | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-01-23 | Traditional | PDF ↗ |
| K772035 | GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL | Harleco | 1977-11-17 | Traditional | PDF ↗ |
| K771622 | MULTISTAT III, AMYLASE TEST | Instrumentation Laboratory CO | 1977-09-13 | Traditional | PDF ↗ |
| K771388 | AMYLASE ULTRAZYME PLUS | Harleco | 1977-09-02 | Traditional | PDF ↗ |
| K771131 | CLINICARD UV AMYLASE CHEMISTRY | Harleco | 1977-07-21 | Traditional | PDF ↗ |
| K770750 | REAGENT KIT, ENZYMATIC AMYLASE | Beckman Instruments, Inc. | 1977-07-05 | Traditional | PDF ↗ |
Product code JFJ · Class II · Clinical Chemistry. Data: openFDA.