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510(k) K191496

Device
TDS Standard Solution
Applicant
Mesa Laboratories, Inc.
510(k) number
K191496
Product code
FKH  
Decision
Substantially Equivalent (SESE)
Decision date
2019-08-05
Date received
2019-06-05
Regulation
876.5820
Classification name
Solution-test Standard-conductivity, Dialysis
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jamie Louie
Address
12100 W. 6th Ave. Lakewood CO US 80228 80228

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FKH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K130100COMINED STANDARD SOLUTIONMesa Laboratories, Inc.2013-04-18
K041636H&S-CONDUCTIVITY STANDARD SOLUTIONH & S Technical Services2004-07-02
K033330CONDUCTIVITY/TDS CALIBRATOR SOLUTIONMesa Laboratories, Inc.2004-02-27
K032075CONDUCTIVITY STANDARD SOLUTION-METERCAREIbp Instruments GmbH2003-09-17
K863824SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT.D.R.G. Scientific Industries1986-10-24
K851362STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OFRna Medical Corp.1985-06-12
K812622HEMODIALYSIS VENOUS & ARTERIAL SETAmisco Trading Corp.1981-09-24

Legacy Summary#

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FDA Review#

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