LJG — Quality Control Slides Class I

FDA Device Classification

Classification Details

Product Code
LJG
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
K943228meridian diagnosticsMICROSPORIDIUM CONTROL SETOctober 27, 1994
K924893scientific device laboratoryMICROSPORIDIUM CONTROL SLIDEJanuary 15, 1993
K890718scientific device laboratoryGRAM STAIN CONTROL SLIDEMarch 16, 1989
K890670scientific device laboratoryCRYPTOSPORIDIUM CONTROL SLIDEMarch 16, 1989
K890616bion entBION DIRECT IDENTIFICATION CONTROL SLIDEFebruary 17, 1989
K883570val tech diagnosticsHISTO-CHECK FUNGAL CONTROL SLIDESOctober 6, 1988
K883571val tech diagnosticsHISTO-CHECK PARASITIC CONTROL SLIDESOctober 6, 1988
K883569val tech diagnosticsHISTO-CHECK GRAM NEGATIVE SLIDESOctober 6, 1988
K883568val tech diagnosticsHISTO-CHECK ACID FAST SLIDESOctober 6, 1988
K883567val tech diagnosticsHISTO-CHECK LEGIONELLA CONTROL SLIDESOctober 6, 1988
K883208val tech diagnosticsHISTO-CHECK SLIDESAugust 25, 1988
K881112sigma diagnosticsFUNGI HISTOLOGY CONTROL SLIDESApril 21, 1988
K881109sigma diagnosticsSPIROCHETES HISTOLOGY CONTROL SLIDESApril 21, 1988
K881106sigma diagnosticsACID FAST BACILLI HISTOLOGY CONTROL SLIDESApril 21, 1988
K881108sigma diagnosticsPNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDESApril 12, 1988
K881110sigma diagnosticsLEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDESApril 12, 1988
K880962alpha-tec systemsATS CRYPTOSPORIDIUM STAIN CONTROL SLIDESMarch 30, 1988
K881107sigma diagnosticsINTRACELLULAR AMYLOID HISTOLOGY CONTROL SLIDESMarch 30, 1988
K881111sigma diagnosticsINTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROLMarch 30, 1988
K840515scientific device laboratoryACID FAST BACILLI STAIN CONTROLMarch 9, 1984