Home / Device Classification / FKH

FKH — Solution-Test Standard-Conductivity, Dialysis Class II

FDA Device Classification

Classification Details

Product Code
FKH
Device Class
Class II
Regulation Number
876.5820
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K191496mesa laboratoriesTDS Standard SolutionAugust 5, 2019
K130100mesa laboratoriesCOMINED STANDARD SOLUTIONApril 18, 2013
K041636h and s technical servicesH&S-CONDUCTIVITY STANDARD SOLUTIONJuly 2, 2004
K033330mesa laboratoriesCONDUCTIVITY/TDS CALIBRATOR SOLUTIONFebruary 27, 2004
K032075ibp instrumentsCONDUCTIVITY STANDARD SOLUTION-METERCARESeptember 17, 2003
K863824d.r.g. scientific industriesSOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT.October 24, 1986
K851362rna medicalSTANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OFJune 12, 1985
K812622amisco tradingHEMODIALYSIS VENOUS & ARTERIAL SETSeptember 24, 1981