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510(k) K851362

Device
STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF
Applicant
RNA MEDICAL CORP.
510(k) number
K851362
Product code
FKH  
Decision
Substantially Equivalent (SESE)
Decision date
1985-06-12
Date received
1985-04-04
Regulation
876.5820
Classification name
Solution-test Standard-conductivity, Dialysis
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ADOLPH E D'AMICO
Address
21 Cummings Park Suite 228 Woburn MA US 01801 01801

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FKH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K191496TDS Standard SolutionMesa Laboratories, Inc.2019-08-05
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
K812622HEMODIALYSIS VENOUS & ARTERIAL SETAmisco Trading Corp.1981-09-24

Legacy Summary#

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FDA Review#

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