Medical Device Manufacturer · US , Chaska , MN

Kallestad Diag, A Div. of Erbamont, Inc.

58 submissions · 58 cleared · Since 1987
58
Total
58
Cleared
0
Denied

Kallestad Diag, A Div. of Erbamont, Inc. — FDA 510(k) Submissions

Kallestad Diag, A Div. of Erbamont, Inc. has submitted 58 FDA 510(k) premarket notifications since 1987, of which 58 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group), Albumin, Antigen, Antiserum, Control, Antistreptolysin - Titer/streptolysin O Reagent, System, Test, Rheumatoid Factor, Igg, Antigen, Antiserum, Control . Use the specialty filter in the sidebar to narrow results.

58 devices
1–25 of 58
QM300 CALIBRATOR G PACK
K910885 · GTQ Antistreptolysin -... · Microbiology
Jun 1991 105d
QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK
K910886 · GTQ Antistreptolysin -... · Microbiology
Jun 1991 105d
QM300 CONTROL G PACK
K910887 · GTQ Antistreptolysin -... · Microbiology
Jun 1991 105d
CHLAMYDIA SYSTEM SOFTWARE (CSS)
K904725 · LJC Enzyme Linked... · Microbiology
Jan 1991 89d
PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT
K902253 · LJC Enzyme Linked... · Microbiology
Jul 1990 66d
MODIFIED QM300 RHEUMATOID FACTOR TEST
K902462 · DHR System, Test, Rheumatoid... · Immunology
Jun 1990 17d
NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR
K900010 · JFT Fluorometric, Cortisol · Toxicology
Apr 1990 91d
NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
K897072 · KLI Enzyme Immunoassay,... · Chemistry
Mar 1990 97d
NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET
K900009 · KLS Enzyme Immunoassay,... · Toxicology
Mar 1990 86d
PLATELIA TOXO IGG KIT
K894947 · LGO Test, Leukocyte Typing · Microbiology
Mar 1990 232d
PLATELIA TOXO IGM KIT
K894948 · LGD Enzyme Linked... · Microbiology
Mar 1990 224d
ALLERCOAT MICROPLATE SYSTEM
K900028 · JJQ Colorimeter, Photometer,... · Immunology
Jan 1990 19d
PLATELIA RUBELLA IGG KIT
K894946 · LFX Enzyme Linked... · Microbiology
Dec 1989 140d
QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK
K896483 · DEB Alpha-2-macroglobulin,... · Immunology
Dec 1989 18d
MODIFIED QM300 ALBUMIN ANTIBODY PACK
K896059 · DCF Albumin, Antigen,... · Immunology
Nov 1989 19d
LP 400 MICROPLATE READER
K894859 · JJQ Colorimeter, Photometer,... · Chemistry
Oct 1989 92d
QM300 CERULOPLASMIN ANTIBODY PACK
K895377 · DDB Ceruloplasmin, Antigen,... · Immunology
Sep 1989 22d
QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK
K894538 · DBN Fc, Antigen, Antiserum,... · Immunology
Aug 1989 15d
QM300 PCR ANTIBODY PACK
K885001 · DCN System, Test, C-reactive... · Immunology
Dec 1988 19d
PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED
K884517 · LJC Enzyme Linked... · Microbiology
Nov 1988 34d
QM300 CONTROL E
K883537 · DHB System, Test,... · Immunology
Nov 1988 78d
QM300 APOLIPOPROTEIN A-I ANTIBODY PACK
K883713 · MSJ Apolipoproteins · Immunology
Oct 1988 50d
QM300 APOLIPOPROTEIN B ANTIBODY PACK
K883714 · MSJ Apolipoproteins · Immunology
Oct 1988 50d
QM300 CALIBRATOR D PACK
K883001 · CZJ Igd, Antigen, Antiserum,... · Immunology
Sep 1988 66d
QM300 PREALBUMIN ANTIBODY PACK
K883002 · JZJ Prealbumin, Antigen,... · Immunology
Sep 1988 66d
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