KIP — Formulations, Balanced Salt Solutions Class I

FDA Device Classification

Classification Details

Product Code
KIP
Device Class
Class I
Regulation Number
864.2875
Submission Type
Review Panel
PA
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K870486sigma chemicalEARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509March 30, 1987
K870484sigma chemicalHANKS' BALANCED SALTS (HBSS) NO. H1387March 30, 1987
K870482sigma chemical(D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030March 30, 1987
K870491sigma chemicalKREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002March 30, 1987
K860784tissue culture innovationsDULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2March 12, 1986
K844877hazleton research productsHEPES BUFFER IM IN NORMAL SALINEFebruary 25, 1985
K844878hazleton research productsTRYPSIN 10X - 1:250 IN HBSS W/O CA & MGFebruary 25, 1985
K842724e k indSALINE 0.85% W/O PRESERVATIVEAugust 3, 1984
K842725e k indSALINE, 0.85%W/PRESERVATIVEAugust 3, 1984
K842723e k indSALINE, 1.3% W/O PRESERVATIVEAugust 3, 1984
K820928dutchland laboratoriesEBS POWDERApril 21, 1982
K820923dutchland laboratoriesDULBECCO'S PBS POWDERApril 21, 1982
K820927dutchland laboratoriesHBS POWDERApril 21, 1982
K810779dutchland laboratoriesEARLE'S BALANCED SALTS SOULTIONMay 13, 1981
K810766dutchland laboratoriesHANKS' BALANCED SALT SOLUTION W/O CA-MGMay 8, 1981
K810777dutchland laboratoriesHANKS' BALANCED SALTS SOLUTION (MODIF.)May 8, 1981
K781391flow laboratoriesPBS FOR FA (46-991-49)August 21, 1978