Panels › Clinical Chemistry › Product code JFJ · Class 2
Catalytic Methods, Amylase
Regulation 862.1070
0510(k)s in 12 months (99 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in JFJ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 26, 2022 | K210633 | Amylase2 Abbott Ireland Diagnostics Division, IE | JFJ |
| Jul 30, 2019 | K191454 | Atellica CH Amylase_2 (AMY_2) Siemens Healthcare Diagnostics, Inc. | JFJ |
| May 2, 2019 | K182474 | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL Biosystems S.A., ES | JFJ |
| Aug 9, 2013 | K130685 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY Hitachi Chemical Diagnostics, Inc. | JFJ |
| Oct 3, 2012 | K122858 | ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II Elitechgroup | JFJ |
| Oct 16, 2009 | K091846 | SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 Beckman Coulter, Inc. | JFJ |
| Nov 17, 2008 | K080823 | EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT Medica Corp. | JFJ |
| May 22, 2007 | K070064 | AMYLASE EPS REAGENT Thermo Fisher Scientific, AU | JFJ |
| Oct 2, 2006 | K062180 | ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP Horiba Abx, FR | JFJ |
| Jan 26, 2006 | K051447 | SENTINEL PANCREATIC AMYLASE Sentinel Ch. Srl, IT | JFJ |
| May 10, 2004 | K040920 | AMYLASE LIQUID REAGENT, MODEL A532-200 Teco Diagnostics | JFJ |
| Mar 11, 2004 | K040534 | VITALAB AMYLASE REAGENT Clinical Data, Inc. | JFJ |
| Dec 9, 2002 | K023549 | WIENER LAB AMILASA 405 AA LIQUIDA Wiener Laboratories Saic, AR | JFJ |
| Feb 28, 2002 | K020282 | JAS AMYLASE LIQUID REAGENT Jas Diagnostics, Inc. | JFJ |
| Jan 15, 2002 | K013978 | SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT Beckman Coulter, Inc. | JFJ |
| Nov 16, 2001 | K013101 | WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA Wiener Laboratories Saic, AR | JFJ |
| Aug 10, 2001 | K011843 | GENZYME DIRECT-AMYLASE TEST REAGENT Genzyme Corp. | JFJ |
| Jun 25, 2001 | K011145 | MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 Roche Diagnostics Corp. | JFJ |
| Jun 26, 2000 | K001569 | INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) Sigma Diagnostics, Inc. | JFJ |
| Feb 8, 1999 | K990025 | CARESIDE AMYLASE Careside, Inc. | JFJ |
| Jan 13, 1999 | K984184 | WAKO L-TYPE AMYLASE Wako Chemicals USA, Inc. | JFJ |
| Aug 28, 1998 | K981653 | AMY Abbott Laboratories | JFJ |
| Jun 8, 1998 | K981216 | AMY Abbott Laboratories | JFJ |
| Dec 17, 1997 | K974125 | IL TEST AMYLASE Instrumentation Laboratory CO | JFJ |
| Dec 8, 1997 | K974053 | AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 Diagnostic Chemicals , Ltd., CA | JFJ |
| Aug 12, 1997 | K972250 | ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS Roche Diagnostic Systems, Inc. | JFJ |
| Jul 24, 1997 | K971825 | PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST Randox Laboratories, Ltd., IE | JFJ |
| Jul 17, 1997 | K972297 | AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) Trace America, Inc. | JFJ |
| May 15, 1995 | K951548 | ACE AMYLASE REAGENT Schiapparelli Biosystems, Inc. | JFJ |
| Feb 8, 1995 | K945243 | CATALOGUE NUMBER 321-07/15/50 Diagnostic Chemicals , Ltd., CA | JFJ |
| Dec 9, 1994 | K944229 | OLYMPUS AMYLASE REAGENT Olympus America, Inc. | JFJ |
| Dec 9, 1994 | K942961 | AMYLASE QVET Prisma Systems | JFJ |
| Sep 9, 1994 | K942640 | DUPONT DIMENSION AMYLASE METHOD Dupont Medical Products | JFJ |
| Jul 6, 1994 | K934293 | BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT Beckman-Diagnostic Systems Group | JFJ |
| May 3, 1994 | K941091 | SYNERMED AMYLASE REAGENT KIT Synermed, Inc., CA | JFJ |
| Apr 12, 1994 | K933682 | DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS Miles, Inc. | JFJ |
| Apr 6, 1994 | K930678 | AMYLASE Horizon Diagnostics, Inc. | JFJ |
| Jan 31, 1994 | K932888 | INTERSECT SYSTEMS DIRECT AMYLASE REAGENT Intersect Systems, Inc. | JFJ |
| Nov 5, 1993 | K931080 | AMYLASE REAGENT SET (KINETIC) Teco Diagnostics | JFJ |
| Oct 28, 1993 | K933397 | GENZYME A-AMYLASE TEST REAGENT Genzyme Corp. | JFJ |
| Aug 19, 1993 | K931583 | SILYL AMYL Em Diagnostic Systems, Inc. | JFJ |
| Aug 19, 1993 | K931582 | ETHYLIDENE AMYL Em Diagnostic Systems, Inc. | JFJ |
| Jul 19, 1993 | K930475 | LIQUID AMYLASE REAGENT SET Pointe Scientific, Inc., | JFJ |
| Oct 2, 1992 | K923346 | OLYMPUS AMYLASE REAGENT Olympus Corp. | JFJ |
| Sep 28, 1992 | K923105 | MILES URINE AMYLASE METHOD Heraeus Kulzer, Inc. | JFJ |
| Sep 9, 1992 | K923677 | AMYLASE TEST Em Diagnostic Systems, Inc. | JFJ |
| Mar 27, 1992 | K921057 | AMYLASE REAGENT Genzyme Corp. | JFJ |
| Mar 2, 1992 | K920583 | ABBOTT QUICKSTART AMYLASE, #5AXX Em Diagnostic Systems, Inc. | JFJ |
| Feb 18, 1992 | K913744 | IL TEST(TM) AMLYLASE Instrumentation Laboratory CO | JFJ |
| Jan 30, 1992 | K915710 | AMYLASE (COLORIMETRIC) REAGENT SET Tech Intl. Co. | JFJ |
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