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LQL — Gram Positive Identification Panel Class I

FDA Device Classification

Classification Details

Product Code
LQL
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
K972576accumed intlGRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90January 22, 1998
K961968bd becton dickinson vacutainer systems preanalyticBBLCRYSTAL GRAM-POSITIVE ID SYSTEMFebruary 4, 1997
K961730becton dickinson microbiology systemsRAPID GRAM-POSITIVE ID SYSTEMFebruary 4, 1997
K952095biomerieux vitekVITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)March 12, 1996
K925916biomerieux vitekVITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARDMarch 23, 1993
K910304vitek systemsRAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIAJuly 26, 1991
K910537kev connecticut diagnosticsVISI-STREPApril 12, 1991
K901559analytical productsMODIFICATION TO API UNISCEPT 20GPSeptember 10, 1990
K891004dms productsRAPIDEC STAPHNovember 9, 1989
K874606mct medicalCATHRA GRAM POSITIVE SCREENMay 6, 1988
K863038american micro scanGRAM POSITIVE FLUORESCENT IDENTIFICATION PANELSeptember 30, 1986