FDA.reportPublic FDA data

510(k) K191454

Device
Atellica CH Amylase_2 (AMY_2)
Applicant
Siemens Healthcare Diagnostics Inc.
510(k) number
K191454
Product code
JFJ  
Decision
Substantially Equivalent (SESE)
Decision date
2019-07-30
Date received
2019-05-31
Regulation
862.1070
Classification name
Catalytic Methods, Amylase
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Catherine Daigle
Address
500 Gbc Dr. P.O. Box 6101. M/S 514 Newark DE US 19714 19714

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JFJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K210633Amylase2Abbott Ireland Diagnostics Division2022-05-26
K182474alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTALBiosystems S.A.2019-05-02
K130685HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMYHitachi Chemical Diagnostics, Inc.2013-08-09
K122858ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL IIElitechgroup2012-10-03
K091846SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607Beckman Coulter, Inc.2009-10-16
K080823EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENTMedica Corp.2008-11-17
K070064AMYLASE EPS REAGENTThermo Fisher Scientific2007-05-22
K062180ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CPHoriba Abx2006-10-02
K051447SENTINEL PANCREATIC AMYLASESentinel Ch. Srl2006-01-26
K040920AMYLASE LIQUID REAGENT, MODEL A532-200Teco Diagnostics2004-05-10
K040534VITALAB AMYLASE REAGENTClinical Data, Inc.2004-03-11
K023549WIENER LAB AMILASA 405 AA LIQUIDAWiener Laboratories Saic2002-12-09
K020282JAS AMYLASE LIQUID REAGENTJas Diagnostics, Inc.2002-02-28
K013978SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENTBeckman Coulter, Inc.2002-01-15
K013101WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AAWiener Laboratories Saic2001-11-16

Legacy Summary#

summary

FDA Review#

Decision Summary