ClearanceBrief
Company ยท US

Kallestad Laboratories, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1986. Name variants (Inc, Corp, punctuation) are merged.

92510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
DGCIge, Antigen, Antiserum, Control8
DHBSystem, Test, Radioallergosorbent (Rast) Immunological5
DEHLambda, Antigen, Antiserum, Control4
CZPIga, Antigen, Antiserum, Control3
DFTIgm, Antigen, Antiserum, Control3
JZSElectrophoresis Instrumentation3
CDPRadioimmunoassay, Total Triiodothyronine2
CZQBence-Jones Protein, Antigen, Antiserum, Control2
DBIComplement C4, Antigen, Antiserum, Control2
DCEFab, Antigen, Antiserum, Control2
DCKC-Reactive Protein, Antigen, Antiserum, And Control2
DDBCeruloplasmin, Antigen, Antiserum, Control2
DEWIgg, Antigen, Antiserum, Control2
DFHKappa, Antigen, Antiserum, Control2
DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control2
LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus2
CDDRadioassay, Vitamin B121
CDXRadioimmunoassay, Total Thyroxine1
CEWRadioimmunoassay, Parathyroid Hormone1
CGNAcid, Folic, Radioimmunoassay1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Dec 3, 1986K863681PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM
Kallestad Laboratories, Inc.
LJP
Oct 22, 1986K862917PATHFINDER ROTAVIRUS CHEMILUMINESCENT
Kallestad Laboratories, Inc.
LIQ
Oct 10, 1986K863682PATHFINDER(TM) SPECIMEN COLLECTION KIT
Kallestad Laboratories, Inc.
JSM
Sep 29, 1986K862743PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS
Kallestad Laboratories, Inc.
GQG
Aug 6, 1986K862313KALLESTAD SM/RNP TEST REAGENT
Kallestad Laboratories, Inc.
LKJ
Jul 29, 1986K862710KALLESTAD SSA/SSB ENA TEST REAGENTS
Kallestad Laboratories, Inc.
LLL
Mar 14, 1986K855014QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A
Kallestad Laboratories, Inc.
JIX
Feb 28, 1986K855010QUANTIMETRIC PLUS IGM REAGENT KIT
Kallestad Laboratories, Inc.
DFT
Feb 26, 1986K855013QUANTIMETRIC PLUS SUPPORT PACK
Kallestad Laboratories, Inc.
DEH
Feb 26, 1986K855012QUANTIMETRIC PLUS C4 REAGENT KIT
Kallestad Laboratories, Inc.
DBI
Feb 26, 1986K855011QUANTIMETRIC PLUS C3 REAGENT KIT
Kallestad Laboratories, Inc.
CZN
Feb 26, 1986K855009QUANTIMETRIC PLUS IGA REAGENT KIT
Kallestad Laboratories, Inc.
CZP
Feb 26, 1986K855008QUANTIMETRIC PLUS KAPPA REAGENT KIT
Kallestad Laboratories, Inc.
DFH
Feb 26, 1986K855007QUANTIMETRIC PLUS LAMBDA REAGENT KIT
Kallestad Laboratories, Inc.
DEH
Dec 11, 1985K854483KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT
Kallestad Laboratories, Inc.
KTO
Nov 26, 1985K853554PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS
Kallestad Laboratories, Inc.
LIQ
Oct 21, 1985K852999QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT
Kallestad Laboratories, Inc.
DEH
Sep 19, 1985K852794ALLERCOAT ALLERGEN DISCS
Kallestad Laboratories, Inc.
DHB
Jul 30, 1985K852125PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP
Kallestad Laboratories, Inc.
GQL
Jul 10, 1985K852268QUANTICLONE IGE RADIOIMMUNASSAY
Kallestad Laboratories, Inc.
DGC
Jul 11, 1984K841864QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT
Kallestad Laboratories, Inc.
DEH
Jun 7, 1984K842125ALLERCOAT ALLERGEN DISCS
Kallestad Laboratories, Inc.
DGC
Mar 9, 1984K840360ALLERCOAT MULTISCREEN DISCS
Kallestad Laboratories, Inc.
DHB
Jun 2, 1983K831326ALLERCOAT ALLERGEN DISCS
Kallestad Laboratories, Inc.
DGC
Dec 15, 1982K823470ALLERCOAT ALLERGEN DISCS
Kallestad Laboratories, Inc.
DHB
Dec 15, 1982K823403ALLERCOAT POSITIVE CONTROL SERUM
Kallestad Laboratories, Inc.
DGC
Nov 16, 1982K823107QUANTIMETRIC 2 CERULOPLASMIN ASSAY
Kallestad Laboratories, Inc.
DDB
Oct 22, 1982K822613RAST ALLERCOAT ALLERGEN DISCS
Kallestad Laboratories, Inc.
DGC
Aug 16, 1982K822206TOTAL IGE DISCS
Kallestad Laboratories, Inc.
DGC
Aug 3, 1982K822133IGE/THE OPHYLLINE CONTROL SERUM I,II,III
Kallestad Laboratories, Inc.
JJY
Jul 22, 1982K821984QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG.
Kallestad Laboratories, Inc.
DCK
Jul 6, 1982K821862QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.
Kallestad Laboratories, Inc.
LCA
Apr 8, 1982K812416MARK 500 SYSTEM
Kallestad Laboratories, Inc.
Apr 6, 1982K820029KALLESTAD RAST REAGENTS
Kallestad Laboratories, Inc.
DHB
Jan 18, 1982K813592QUANTAFLUOR FLUORESCENT TEST REAGENTS
Kallestad Laboratories, Inc.
DHN
Dec 2, 1981K813242QUANTIMETRIC 2 TEST KIT
Kallestad Laboratories, Inc.
KEW
Nov 10, 1981K812411IMMUNO-CELL IMMUNO-SEP KIT
Kallestad Laboratories, Inc.
JCF
Oct 2, 1981K812611QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO
Kallestad Laboratories, Inc.
CDP
Sep 14, 1981K812414KALLESTAD 125I ANTISERUM TO HUMAN IGE
Kallestad Laboratories, Inc.
DHB
Sep 9, 1981K812415KALLESTAD ANTISERA TO TOBRAMYCIN
Kallestad Laboratories, Inc.
KLB
Sep 1, 1981K812327KAPPA & LAMBDA BENCE JONES CONTROLS
Kallestad Laboratories, Inc.
CZQ
Aug 3, 1981K812050KALLESTAD ANTISERA TO GENTAMICIN
Kallestad Laboratories, Inc.
DJI
Jul 16, 1981K811740KALLESTAD'S ENDOPLATE FACTOR B TEST
Kallestad Laboratories, Inc.
JZH
Jul 10, 1981K811776KALLESTAD QUANTICOAT 125 DIGOXIN
Kallestad Laboratories, Inc.
DPO
Jul 10, 1981K811775KALLESTAD ANTISERA TO PHENYTOIN
Kallestad Laboratories, Inc.
DLP
Jun 25, 1981K811617QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R.
Kallestad Laboratories, Inc.
DCK
Jun 24, 1981K811545KALLESTAD QUANTITOPE LOW LEVEL IGE REAG
Kallestad Laboratories, Inc.
DGC
Jun 24, 1981K811445KALLESTAD R QUANTIPLATE ALT. PATHWAY T.
Kallestad Laboratories, Inc.
DHL
May 29, 1981K811367KALLESTAD ANTISERA TO PHENOBARBITAL
Kallestad Laboratories, Inc.
DLZ
Apr 14, 1981K810863KALLESTAD HEP-2 CELL LINE SUBSTRATE
Kallestad Laboratories, Inc.
DBM

Newest 50 of 92.

Latest recalls

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