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JTS — Stains, Microbiologic Class I

FDA Device Classification

Classification Details

Product Code
JTS
Device Class
Class I
Regulation Number
864.1850
Submission Type
Review Panel
MI
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K960095remelBACTIDROP CALCOFLUOR WHITEMarch 19, 1996
K960090remelCALCOFLUOR WHITE STAIN KITMarch 19, 1996
K920970remelBACTIDROP KOH (10%)June 9, 1992
K920976remelBACTIDROP INDIA INKJune 9, 1992
K920975remelBACTIDROP CALCOFLUOR WHITEJune 9, 1992
K893530intl. remote imaging systemsIRISTAIN FORMULA 2, PARTS 1 AND 2June 13, 1989
K890861alpha-tec systemsATS DOBELL & O'CONNOR'S IODINEMarch 23, 1989
K890020alpha-tec systemsATS LUGOL'S IODINE SOLUTIONFebruary 24, 1989
K884069scientific device laboratorySNAP N' STAIN IODINE STAINOctober 25, 1988
K883052scientific device laboratoryMETHENO-STAIN KITAugust 30, 1988
K883061alpha-tech systemsATS PARA-SET CARBOL-XYLENE SOLUTIONAugust 17, 1988
K883049alpha-tec systemsATS PARA-SET IODINE ALCOHOL SOLUTIONAugust 17, 1988
K880989alpha-tec systemsATS CRYPTOSPORIDIUM STAIN SETMay 13, 1988
K881598scientific device laboratorySDL TRICHROME STAINMay 4, 1988
K881512wescorWESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAYApril 18, 1988
K881042alpha-tec systemsATS TRICHROME STAIN (WHEATLEY'S MODIFICATION)March 30, 1988
K880718remelCALCOFLUOR WHITE STAIN KITMarch 25, 1988
K874662scott laboratoriesMYCO-FLUOR REAGENT A & BNovember 25, 1987
K873413lakewood biochemical coGRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFROctober 6, 1987
K872189remelMETHANOL, ABSOLUTEJuly 29, 1987