Atlas FDA

JFJ

99 FDA 510(k) clearances · Product code

57 daysmedian time to decision
182 days90th percentile
99clearances measured

FDA profile

Official device name
Catalytic Methods, Amylase
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1070
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
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RecordFirmDate
Amylase2 (K210633)Abbott Ireland Diagnostics Division2022-05-26
Atellica CH Amylase_2 (AMY_2) (K191454)Siemens Healthcare Diagnostics, Inc.2019-07-30
alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL (K182474)Biosystems S.A.2019-05-02
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY (K130685)Hitachi Chemical Diagnostics, Inc.2013-08-09
ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II (K122858)Elitechgroup2012-10-03
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 (K091846)Beckman Coulter, Inc.2009-10-16
EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT (K080823)Medica Corp.2008-11-17
AMYLASE EPS REAGENT (K070064)Thermo Fisher Scientific2007-05-22
ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP (K062180)Horiba Abx2006-10-02
SENTINEL PANCREATIC AMYLASE (K051447)Sentinel Ch. Srl2006-01-26
AMYLASE LIQUID REAGENT, MODEL A532-200 (K040920)Teco Diagnostics2004-05-10
VITALAB AMYLASE REAGENT (K040534)Clinical Data, Inc.2004-03-11
WIENER LAB AMILASA 405 AA LIQUIDA (K023549)Wiener Laboratories Saic2002-12-09
JAS AMYLASE LIQUID REAGENT (K020282)Jas Diagnostics, Inc.2002-02-28
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT (K013978)Beckman Coulter, Inc.2002-01-15
WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA (K013101)Wiener Laboratories Saic2001-11-16
GENZYME DIRECT-AMYLASE TEST REAGENT (K011843)Genzyme Corp.2001-08-10
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 (K011145)Roche Diagnostics Corp.2001-06-25
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) (K001569)Sigma Diagnostics, Inc.2000-06-26
CARESIDE AMYLASE (K990025)Careside, Inc.1999-02-08
WAKO L-TYPE AMYLASE (K984184)Wako Chemicals USA, Inc.1999-01-13
AMY (K981653)Abbott Laboratories1998-08-28
AMY (K981216)Abbott Laboratories1998-06-08
IL TEST AMYLASE (K974125)Instrumentation Laboratory CO1997-12-17
AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 (K974053)Diagnostic Chemicals , Ltd.1997-12-08
ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS (K972250)Roche Diagnostic Systems, Inc.1997-08-12
PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST (K971825)Randox Laboratories, Ltd.1997-07-24
AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (K972297)Trace America, Inc.1997-07-17
ACE AMYLASE REAGENT (K951548)Schiapparelli Biosystems, Inc.1995-05-15
CATALOGUE NUMBER 321-07/15/50 (K945243)Diagnostic Chemicals , Ltd.1995-02-08
AMYLASE QVET (K942961)Prisma Systems1994-12-09
OLYMPUS AMYLASE REAGENT (K944229)Olympus America, Inc.1994-12-09
DUPONT DIMENSION AMYLASE METHOD (K942640)Dupont Medical Products1994-09-09
BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT (K934293)Beckman-Diagnostic Systems Group1994-07-06
SYNERMED AMYLASE REAGENT KIT (K941091)Synermed, Inc.1994-05-03
DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS (K933682)Miles, Inc.1994-04-12
AMYLASE (K930678)Horizon Diagnostics, Inc.1994-04-06
INTERSECT SYSTEMS DIRECT AMYLASE REAGENT (K932888)Intersect Systems, Inc.1994-01-31
AMYLASE REAGENT SET (KINETIC) (K931080)Teco Diagnostics1993-11-05
GENZYME A-AMYLASE TEST REAGENT (K933397)Genzyme Corp.1993-10-28
SILYL AMYL (K931583)Em Diagnostic Systems, Inc.1993-08-19
ETHYLIDENE AMYL (K931582)Em Diagnostic Systems, Inc.1993-08-19
LIQUID AMYLASE REAGENT SET (K930475)Pointe Scientific, Inc.,1993-07-19
OLYMPUS AMYLASE REAGENT (K923346)Olympus Corp.1992-10-02
MILES URINE AMYLASE METHOD (K923105)Heraeus Kulzer, Inc.1992-09-28
AMYLASE TEST (K923677)Em Diagnostic Systems, Inc.1992-09-09
AMYLASE REAGENT (K921057)Genzyme Corp.1992-03-27
ABBOTT QUICKSTART AMYLASE, #5AXX (K920583)Em Diagnostic Systems, Inc.1992-03-02
IL TEST(TM) AMLYLASE (K913744)Instrumentation Laboratory CO1992-02-18
AMYLASE (COLORIMETRIC) REAGENT SET (K915710)Tech Intl. Co.1992-01-30
AMYLASE REAGENT (PROCEDURE 577) (K913858)Sigma Diagnostics, Inc.1991-09-11
AMYLASE REAGENT (K912519)Genzyme Corp.1991-07-01
AMYLASE (K910158)Pointe Scientific, Inc.,1991-04-30
KINETIC AMYLASE DETERMINATION (K905651)Biochemical Trade, Inc.1991-01-31
ROCHE COBAS READY AMYLASE REAGENT (K903309)Roche Diagnostic Systems, Inc.1990-09-07
SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404 (K903332)Em Diagnostic Systems, Inc.1990-08-17
AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS (K902326)Catachem, Inc.1990-07-31
DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI (K901017)E.I. Dupont DE Nemours & Co., Inc.1990-05-15
COULTER AMYLASE REAGENT (K900230)Coulter Corp.1990-04-03
AMYLASE REAGENT (K896650)Sigma Chemical Co.1990-02-08
AMYLASE TEST (AML) ITEM NUMBER: 65404 (K893751)Em Diagnostic Systems, Inc.1989-08-17
ABBOTT SPECTRUM AMYLASE REAGENT (K891241)Abbott Laboratories1989-08-15
PANCREATIC A-AMYLASE PNP (K892848)Boehringer Mannheim Corp.1989-07-20
AMYLASE SR LIQUID STABLE REAGENT SET (K885176)Medical Analysis Systems, Inc.1989-02-17
AMYLASE 405 CATALOG NUMBER 301-34 (K880867)Diagnostic Chemicals, Ltd. (Usa)1988-04-19
REFLOTRON (R) AMYLASE (K874704)Boehringer Mannheim Corp.1988-01-05
A-GENT LIQUID AMYLASE (K873944)Abbott Laboratories1987-11-23
BNP-AMYLASE TEST (K873133)Sclavo, Inc.1987-10-06
AMYLASE TEST KIT (K872023)Ciba Corning Diagnostics Corp.1987-08-05
STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715 (K870746)Stanbio Laboratory1987-06-01
RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C) (K871269)Technicon Instruments Corp.1987-04-13
AMYLASE COLORIMETRIC PROCEDURE (K864825)Data Medical Associates, Inc.1987-02-20
PSI AMYLASE REAGENT (K864464)Pointe Scientific, Inc.,1987-01-21
QKO (TM) AMYLASE B-HA (K864303)Wako Chemicals USA, Inc.1986-12-31
VISION(TM) AMYLASE (K864435)Abbott Laboratories1986-12-16
TDX(R) AMYLASE II (K863622)Abbott Laboratories1986-10-03
AMYLASE PROCEDURE (K863588)Data Medical Associates, Inc.1986-09-29
AMYLASE SR LIQUID STABLE REAGENT SET (K862733)Medical Analysis Systems, Inc.1986-09-29
RAICHEM AMYLASE REAGENT (K861269)Reagents Applications, Inc.1986-05-29
AMYLASE REAGENT CATALOGUE NOS. 85108 AND 85109 (K861718)Reagents Applications, Inc.1986-05-29
ALPHA-AMYLASE TEST (K860665)Sclavo, Inc.1986-04-07
EASY-TEST AMLASE (AMYL), #67521/93 (K860918)Em Diagnostic Systems, Inc.1986-04-03
ENZYMATIC ALPHA-AMYLASE REAGENT KIT (K860245)Bio-Analytics Laboratories, Inc.1986-03-14
AMY REAGENT (K852001)Alpkem Corp.1985-06-10
AMYLASE PRODUCTS (K850798)Data Medical Associates, Inc.1985-03-14
AMYLASE (K832889)Pointe Scientific, Inc.,1983-11-25
AMYLAST-D TEST (K831561)Sclavo, Inc.1983-07-07
PARAMAX AMALINE REAGENT (K831536)American Dade1983-06-17
SINGLE VIAL AMYLASE PNP TEST (K823462)Boehringer Mannheim Corp.1982-12-28
ULTRAZYME PLUS AMYL (K821869)Harleco Diagnostics1982-07-13
ULTRAZYME PLUS AMYL #65031&64982 (K821459)Emd Chemicals, Inc.1982-05-28
BEKCMAN ASTRA SYSTEMS AMYLASE CHEMISTRY (K802581)Beckman Instruments, Inc.1980-11-12
COBAS REAGENT FOR A-AMYLASE (K801295)Roche Analytical Instruments, Inc.1980-07-08
DELTA TEST AMYLASE UV (K800049)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-01-23
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL (K772035)Harleco1977-11-17
MULTISTAT III, AMYLASE TEST (K771622)Instrumentation Laboratory CO1977-09-13
AMYLASE ULTRAZYME PLUS (K771388)Harleco1977-09-02
CLINICARD UV AMYLASE CHEMISTRY (K771131)Harleco1977-07-21
REAGENT KIT, ENZYMATIC AMYLASE (K770750)Beckman Instruments, Inc.1977-07-05

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