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Kallestad Diag, A Div. of Erbamont, Inc.

FDA 510(k) & PMA Approved Devices — 58 products

Total Devices58
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K910886 QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACKGTQ1991-06-17 View
510(k) K910885 QM300 CALIBRATOR G PACKGTQ1991-06-17 View
510(k) K910887 QM300 CONTROL G PACKGTQ1991-06-17 View
510(k) K904725 CHLAMYDIA SYSTEM SOFTWARE (CSS)LJC1991-01-14 View
510(k) K902253 PATHFINDER(TM) CHLAMYDIA MICROPLATE KITLJC1990-07-26 View
510(k) K902462 MODIFIED QM300 RHEUMATOID FACTOR TESTDHR1990-06-21 View
510(k) K900010 NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATORJFT1990-04-03 View
510(k) K900009 NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SETKLS1990-03-29 View
510(k) K897072 NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATORKLI1990-03-29 View
510(k) K894947 PLATELIA TOXO IGG KITLGO1990-03-23 View
510(k) K894948 PLATELIA TOXO IGM KITLGD1990-03-15 View
510(k) K900028 ALLERCOAT MICROPLATE SYSTEMJJQ1990-01-22 View
510(k) K894946 PLATELIA RUBELLA IGG KITLFX1989-12-21 View
510(k) K896483 QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACKDEB1989-12-01 View
510(k) K896059 MODIFIED QM300 ALBUMIN ANTIBODY PACKDCF1989-11-06 View
510(k) K894859 LP 400 MICROPLATE READERJJQ1989-10-31 View
510(k) K895377 QM300 CERULOPLASMIN ANTIBODY PACKDDB1989-09-21 View
510(k) K894538 QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACKDBN1989-08-04 View
510(k) K885001 QM300 PCR ANTIBODY PACKDCN1988-12-20 View
510(k) K884517 PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIEDLJC1988-11-30 View
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