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JZT — Fluorometer Class I

FDA Device Classification

Classification Details

Product Code
JZT
Device Class
Class I
Regulation Number
866.4520
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K962499bartelsZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READERSeptember 5, 1996
K883349bd becton dickinson vacutainer systems preanalyticQLIA IMMUNOCHEMISTRY SYSTEMSeptember 7, 1988
K882677weaver medicalSTAT-20 FLUOROMETERJuly 12, 1988
K864699pandex laboratoriesFLUORESCENCE CONCENTRATION ANALYZER (FCA)December 22, 1986
K863434whittaker bioproductsTHE FIAX 5000 FLUOROMETEROctober 29, 1986
K862674hybritechPHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEMAugust 15, 1986
K852240pandex laboratoriesSMS, SCREEN MACHINE SYSTEMJune 11, 1985
K842049flow laboratoriesFLUOROSKANDecember 3, 1984
K843356intl. diagnostic technologyFIAX 100 FLUOROMETERSeptember 17, 1984
K834070paragon diagnosticsIMMPULSE SYSTEMMarch 23, 1984
K831870axonicsALLERGENETICS FLUORO-FAST READERAugust 12, 1983
K800698california immuno diagnosticAUTOFLUOR SYSTEMMay 28, 1980
K782150dade, baxter travenol diagnosticsFLUROMETER, DADEFebruary 15, 1979
K770662corning medical and scientificVIEWER, FLUOROMETIC, MODEL 721April 15, 1977