Medical Device Manufacturer · US , Mchenry , IL

Kallestad Laboratories, Inc.

92 submissions · 92 cleared · Since 1976
92
Total
92
Cleared
0
Denied

Kallestad Laboratories, Inc. — FDA 510(k) Submissions

Kallestad Laboratories, Inc. has submitted 92 FDA 510(k) premarket notifications since 1976, of which 92 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Ige, Antigen, Antiserum, Control, System, Test, Radioallergosorbent (rast) Immunological, Lambda, Antigen, Antiserum, Control, Electrophoresis Instrumentation, Iga, Antigen, Antiserum, Control . Use the specialty filter in the sidebar to narrow results.

92 devices
1–25 of 92
PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM
K863681 · LJP Antiserum, Fluorescent,... · Microbiology
Dec 1986 75d
PATHFINDER ROTAVIRUS CHEMILUMINESCENT
K862917 · LIQ Enzyme Linked... · Microbiology
Oct 1986 82d
PATHFINDER(TM) SPECIMEN COLLECTION KIT
K863682 · JSM Culture Media,... · Microbiology
Oct 1986 21d
PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS
K862743 · GQG Antigen, Cf (including Cf... · Microbiology
Sep 1986 70d
KALLESTAD SM/RNP TEST REAGENT
K862313 · LKJ Antinuclear Antibody,... · Immunology
Aug 1986 49d
KALLESTAD SSA/SSB ENA TEST REAGENTS
K862710 · LLL Extractable Antinuclear... · Immunology
Jul 1986 13d
QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A
K855014 · JIX Calibrator, Multi-analyte... · Immunology
Mar 1986 88d
QUANTIMETRIC PLUS IGM REAGENT KIT
K855010 · DFT Igm, Antigen, Antiserum,... · Immunology
Feb 1986 74d
QUANTIMETRIC PLUS LAMBDA REAGENT KIT
K855007 · DEH Lambda, Antigen,... · Immunology
Feb 1986 72d
QUANTIMETRIC PLUS KAPPA REAGENT KIT
K855008 · DFH Kappa, Antigen,... · Immunology
Feb 1986 72d
QUANTIMETRIC PLUS IGA REAGENT KIT
K855009 · CZP Iga, Antigen, Antiserum,... · Immunology
Feb 1986 72d
QUANTIMETRIC PLUS C3 REAGENT KIT
K855011 · CZN Iga, Fitc, Antigen,... · Immunology
Feb 1986 72d
QUANTIMETRIC PLUS C4 REAGENT KIT
K855012 · DBI Complement C4, Antigen,... · Immunology
Feb 1986 72d
QUANTIMETRIC PLUS SUPPORT PACK
K855013 · DEH Lambda, Antigen,... · Immunology
Feb 1986 72d
KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT
K854483 · KTO Reagent, Immunoassay, Igg · Immunology
Dec 1985 34d
PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS
K853554 · LIQ Enzyme Linked... · Microbiology
Nov 1985 92d
QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT
K852999 · DEH Lambda, Antigen,... · Immunology
Oct 1985 98d
ALLERCOAT ALLERGEN DISCS
K852794 · DHB System, Test,... · Immunology
Sep 1985 80d
PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP
K852125 · GQL Antisera, Fluorescent,... · Microbiology
Jul 1985 76d
QUANTICLONE IGE RADIOIMMUNASSAY
K852268 · DGC Ige, Antigen, Antiserum,... · Immunology
Jul 1985 43d
QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT
K841864 · DEH Lambda, Antigen,... · Immunology
Jul 1984 68d
ALLERCOAT ALLERGEN DISCS
K842125 · DGC Ige, Antigen, Antiserum,... · Immunology
Jun 1984 9d
ALLERCOAT MULTISCREEN DISCS
K840360 · DHB System, Test,... · Immunology
Mar 1984 43d
ALLERCOAT ALLERGEN DISCS
K831326 · DGC Ige, Antigen, Antiserum,... · Immunology
Jun 1983 38d
ALLERCOAT POSITIVE CONTROL SERUM
K823403 · DGC Ige, Antigen, Antiserum,... · Immunology
Dec 1982 30d

Looking for a specific device from Kallestad Laboratories, Inc.? Search by device name or K-number.

Search all Kallestad... devices
Filters