Home / Companies / Kallestad Diag, A Div. of Erbamont, Inc.

Kallestad Diag, A Div. of Erbamont, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
58
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K910885QM300 CALIBRATOR G PACKJune 17, 1991
K910887QM300 CONTROL G PACKJune 17, 1991
K910886QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACKJune 17, 1991
K904725CHLAMYDIA SYSTEM SOFTWARE (CSS)January 14, 1991
K902253PATHFINDER(TM) CHLAMYDIA MICROPLATE KITJuly 26, 1990
K902462MODIFIED QM300 RHEUMATOID FACTOR TESTJune 21, 1990
K900010NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATORApril 3, 1990
K900009NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SETMarch 29, 1990
K897072NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATORMarch 29, 1990
K894947PLATELIA TOXO IGG KITMarch 23, 1990
K894948PLATELIA TOXO IGM KITMarch 15, 1990
K900028ALLERCOAT MICROPLATE SYSTEMJanuary 22, 1990
K894946PLATELIA RUBELLA IGG KITDecember 21, 1989
K896483QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACKDecember 1, 1989
K896059MODIFIED QM300 ALBUMIN ANTIBODY PACKNovember 6, 1989
K894859LP 400 MICROPLATE READEROctober 31, 1989
K895377QM300 CERULOPLASMIN ANTIBODY PACKSeptember 21, 1989
K894538QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACKAugust 4, 1989
K885001QM300 PCR ANTIBODY PACKDecember 20, 1988
K884517PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIEDNovember 30, 1988