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Kallestad Laboratories, Inc.

FDA 510(k) & PMA Approved Devices — 92 products

Total Devices92
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K863681 PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEMLJP1986-12-03 View
510(k) K862917 PATHFINDER ROTAVIRUS CHEMILUMINESCENTLIQ1986-10-22 View
510(k) K863682 PATHFINDER(TM) SPECIMEN COLLECTION KITJSM1986-10-10 View
510(k) K862743 PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUSGQG1986-09-29 View
510(k) K862313 KALLESTAD SM/RNP TEST REAGENTLKJ1986-08-06 View
510(k) K862710 KALLESTAD SSA/SSB ENA TEST REAGENTSLLL1986-07-29 View
510(k) K855014 QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET AJIX1986-03-14 View
510(k) K855010 QUANTIMETRIC PLUS IGM REAGENT KITDFT1986-02-28 View
510(k) K855009 QUANTIMETRIC PLUS IGA REAGENT KITCZP1986-02-26 View
510(k) K855007 QUANTIMETRIC PLUS LAMBDA REAGENT KITDEH1986-02-26 View
510(k) K855012 QUANTIMETRIC PLUS C4 REAGENT KITDBI1986-02-26 View
510(k) K855013 QUANTIMETRIC PLUS SUPPORT PACKDEH1986-02-26 View
510(k) K855011 QUANTIMETRIC PLUS C3 REAGENT KITCZN1986-02-26 View
510(k) K855008 QUANTIMETRIC PLUS KAPPA REAGENT KITDFH1986-02-26 View
510(k) K854483 KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KITKTO1985-12-11 View
510(k) K853554 PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUSLIQ1985-11-26 View
510(k) K852999 QVANTIMETRIC 2KAPPA AND LAMBDA TEST KITDEH1985-10-21 View
510(k) K852794 ALLERCOAT ALLERGEN DISCSDHB1985-09-19 View
510(k) K852125 PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMPGQL1985-07-30 View
510(k) K852268 QUANTICLONE IGE RADIOIMMUNASSAYDGC1985-07-10 View
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