LIB — Device, General Purpose, Microbiology, Diagnostic Class I

FDA Device Classification

Classification Details

Product Code
LIB
Device Class
Class I
Regulation Number
866.2660
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K023677osmetechOSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)January 29, 2003
K920416behring diagnosticsSUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMBApril 8, 1992
K912558gull laboratoriesGULL ELISAWARESeptember 16, 1991
K872273corning medical and scientificCORNING EASY WASH ELISA PLATESJuly 7, 1987
K871559corning costarCELL LIFTERMay 15, 1987
K864249mds laboratoriesNORMAL SALINE STERILEMarch 31, 1987
K863789corning medical and scientificCORNING ELISA PLATESOctober 3, 1986
K862112abco dealersMICROSCOPE SLIDESJune 13, 1986
K854604dynatechAUTO MASHDecember 6, 1985
K854602dynatechMINI MASH 2000December 6, 1985
K854603dynatechMULTI MASH 2000December 6, 1985
K854423dynatech laboratoriesIMMULON 1 EIA TUBES, IMMULON 2 EIA TUBESNovember 20, 1985
K853285scientific sales intlMYWASHER 5October 4, 1985
K853745microtech medical systemsMIC-CONCEPT VIEWBOXSeptember 19, 1985
K850725microtech medical systemsQUADRA TITER MICRO PLATESApril 30, 1985
K844476portable medical laboratoriesPORTABLE DIAGNOSTIC LABORATORYMarch 13, 1985
K844442portable medical laboratoriesRAPID DIAGNOSTIC KITFebruary 1, 1985
K844473portable medical laboratoriesHAND-HELD SLIDE READERJanuary 4, 1985
K843483zimmar consultingPHARMA-PLAST PETRI DISHSeptember 21, 1984
K842052gelman sciencesGIARDIA GUARDSeptember 11, 1984