Kallestad Laboratories, Inc.
Medical device manufacturer in Chaska, MN.
92510(k) clearances
0PMA approvals
0recalls
Device types
- DGC Ige, Antigen, Antiserum, Control 8
- DHB System, Test, Radioallergosorbent (Rast)… 5
- DEH Lambda, Antigen, Antiserum, Control 4
- JZS Electrophoresis Instrumentation 3
- CZP Iga, Antigen, Antiserum, Control 3
- DFT Igm, Antigen, Antiserum, Control 3
- CZQ Bence-Jones Protein, Antigen, Antiserum… 2
- DHN Antinuclear Antibody, Indirect… 2
- LIQ Enzyme Linked Immunoabsorbent Assay… 2
- DDB Ceruloplasmin, Antigen, Antiserum, Control 2
- DFH Kappa, Antigen, Antiserum, Control 2
- DCK C-Reactive Protein, Antigen, Antiserum, And… 2
- DBI Complement C4, Antigen, Antiserum, Control 2
- DCE Fab, Antigen, Antiserum, Control 2
- DEW Igg, Antigen, Antiserum, Control 2
- CDP Radioimmunoassay, Total Triiodothyronine 2
- CEW Radioimmunoassay, Parathyroid Hormone 1
- DEB Alpha-2-Macroglobulin, Antigen, Antiserum… 1
- DAD Haptoglobin, Antigen, Antiserum, Control 1
- LJP Antiserum, Fluorescent, Chlamydia Trachomatis 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K863681 | Pathfinder(Tm) Direct Antigen Detection SystemLJP · Traditional | 12/03/1986SE |
| K862917 | Pathfinder Rotavirus ChemiluminescentLIQ · Traditional | 10/22/1986SE |
| K863682 | Pathfinder(Tm) Specimen Collection KitJSM · Traditional | 10/10/1986SE |
| K862743 | Pathfinder(Tm) Respiratory Syncytial VirusGQG · Traditional | 09/29/1986SE |
| K862313 | Kallestad Sm/Rnp Test ReagentLKJ · Traditional | 08/06/1986SE |
| K862710 | Kallestad Ssa/Ssb Ena Test ReagentsLLL · Traditional | 07/29/1986SE |
| K855014 | Quantimetric Plus Calibrator/Control Set aJIX · Traditional | 03/14/1986SE |
| K855010 | Quantimetric Plus Igm Reagent KitDFT · Traditional | 02/28/1986SE |
| K855013 | Quantimetric Plus Support PackDEH · Traditional | 02/26/1986SE |
| K855012 | Quantimetric Plus C4 Reagent KitDBI · Traditional | 02/26/1986SE |
| K855011 | Quantimetric Plus C3 Reagent KitCZN · Traditional | 02/26/1986SE |
| K855009 | Quantimetric Plus Iga Reagent KitCZP · Traditional | 02/26/1986SE |
| K855008 | Quantimetric Plus Kappa Reagent KitDFH · Traditional | 02/26/1986SE |
| K855007 | Quantimetric Plus Lambda Reagent KitDEH · Traditional | 02/26/1986SE |
| K854483 | Kallestad Quantimetric Plus Igg Reagent KitKTO · Traditional | 12/11/1985SE |
| K853554 | Pathfinder Direct Antigen Detection Sys RotavirusLIQ · Traditional | 11/26/1985SE |
| K852999 | Qvantimetric 2KAPPA and Lambda Test KitDEH · Traditional | 10/21/1985SE |
| K852794 | Allercoat Allergen DiscsDHB · Traditional | 09/19/1985SE |
| K852125 | Pathfinder Detection & Collection Kits-Herpes SimpGQL · Traditional | 07/30/1985SE |
| K852268 | Quanticlone Ige RadioimmunassayDGC · Traditional | 07/10/1985SE |
| K841864 | Quantimetric TM 2 Kappa & Lambda KitDEH · Traditional | 07/11/1984SE |
| K842125 | Allercoat Allergen DiscsDGC · Traditional | 06/07/1984SE |
| K840360 | Allercoat Multiscreen DiscsDHB · Traditional | 03/09/1984SE |
| K831326 | Allercoat Allergen DiscsDGC · Traditional | 06/02/1983SE |
| K823470 | Allercoat Allergen DiscsDHB · Traditional | 12/15/1982SE |
| K823403 | Allercoat Positive Control SerumDGC · Traditional | 12/15/1982SE |
| K823107 | Quantimetric 2 Ceruloplasmin AssayDDB · Traditional | 11/16/1982SE |
| K822613 | Rast Allercoat Allergen DiscsDGC · Traditional | 10/22/1982SE |
| K822206 | Total Ige DiscsDGC · Traditional | 08/16/1982SE |
| K822133 | Ige/The Ophylline Control Serum I,Ii,IiiJJY · Traditional | 08/03/1982SE |
| K821984 | Quantimetric 2 C-Reactive Protein Reag.DCK · Traditional | 07/22/1982SE |
| K821862 | Quanticoat 125 I-Theophylline Radioimm.LCA · Traditional | 07/06/1982SE |
| K812416 | Mark 500 System · Traditional | 04/08/1982SE |
| K820029 | Kallestad Rast ReagentsDHB · Traditional | 04/06/1982SE |
| K813592 | Quantafluor Fluorescent Test ReagentsDHN · Traditional | 01/18/1982SE |
| K813242 | Quantimetric 2 Test KitKEW · Traditional | 12/02/1981SE |
| K812411 | Immuno-Cell Immuno-Sep KitJCF · Traditional | 11/10/1981SE |
| K812611 | Quanticoat Neonatal 125 T4 RadioimmunoCDP · Traditional | 10/02/1981SE |
| K812414 | Kallestad 125I Antiserum to Human IgeDHB · Traditional | 09/14/1981SE |
| K812415 | Kallestad Antisera to TobramycinKLB · Traditional | 09/09/1981SE |
| K812327 | Kappa & Lambda Bence Jones ControlsCZQ · Traditional | 09/01/1981SE |
| K812050 | Kallestad Antisera to GentamicinDJI · Traditional | 08/03/1981SE |
| K811740 | Kallestad's Endoplate Factor B TestJZH · Traditional | 07/16/1981SE |
| K811776 | Kallestad Quanticoat 125 DigoxinDPO · Traditional | 07/10/1981SE |
| K811775 | Kallestad Antisera to PhenytoinDLP · Traditional | 07/10/1981SE |
| K811617 | Quantimetric C-Reactive Protein Assay R.DCK · Traditional | 06/25/1981SE |
| K811545 | Kallestad Quantitope Low Level Ige ReagDGC · Traditional | 06/24/1981SE |
| K811445 | Kallestad R Quantiplate Alt. Pathway T.DHL · Traditional | 06/24/1981SE |
| K811367 | Kallestad Antisera to PhenobarbitalDLZ · Traditional | 05/29/1981SE |
| K810863 | Kallestad HEP-2 Cell Line SubstrateDBM · Traditional | 04/14/1981SE |
| K802284 | Antisera to Human Free Lambda Light Ch.CZQ · Traditional | 10/23/1980SE |
| K802283 | Antisera to Human Free Kappa ChainsDFH · Traditional | 10/23/1980SE |
| K792610 | Kallestad Florescent Ana/Ama/Asma TestDBL · Traditional | 02/22/1980SE |
| K790588 | Assay Reagents, Lsa 290JEW · Traditional | 05/15/1979SE |
| K790298 | Radioassay, Control Serum I, II, IIIDGR · Traditional | 04/04/1979SE |
| K781951 | Antisera, Rhodamine Conjugated FragmentDCE · Traditional | 02/16/1979SE |
| K781904 | Ria Kit, Quantitope IgeDGC · Traditional | 02/08/1979SE |
| K781903 | Ria Kit, Quantitope CortisolCGR · Traditional | 01/26/1979SE |
| K782052 | Processor, K750 Computer/DataJQP · Traditional | 01/17/1979SE |
| K781905 | Ria Kit, Quantitope T3 UptakeKHQ · Traditional | 01/03/1979SE |
| K781883 | Diluter, Lsa 290 PipetterJQW · Traditional | 12/04/1978SE |
| K780899 | Fluorescent Anti-Native DNA TestDHN · Traditional | 09/07/1978SE |
| K780508 | Quantitope 125I-FOLATE Radioassay KitCGN · Traditional | 05/03/1978SE |
| K780251 | NephelometerJQX · Traditional | 04/06/1978SE |
| K780323 | Quantitope 125-I Gentamicin Ria KitDJB · Traditional | 03/17/1978SE |
| K780250 | Hemopexin Nephelometric AssaysCZX · Traditional | 02/28/1978SE |
| K772345 | Fluorescein Conjug. Fract. Mono. Anti.DCB · Traditional | 01/05/1978SE |
| K772255 | Ceruloplasmin Nephel. AssayDDB · Traditional | 01/05/1978SE |
| K772254 | Immunoglobulin M Nephel. AssayDFT · Traditional | 12/22/1977SE |
| K772253 | Transferrin Nephelometric AssayDDG · Traditional | 12/22/1977SE |
| K772252 | Immunoglobulin G Nephel. AssayDEW · Traditional | 12/22/1977SE |
| K772251 | Immunoglobulin a Nephel. AssayCZP · Traditional | 12/22/1977SE |
| K772250 | ALPHA-1-ANTITRYPSIN Nephel. AssayDEI · Traditional | 12/22/1977SE |
| K772249 | Complement C3 Nephelometric AssayCEW · Traditional | 12/22/1977SE |
| K772248 | Albumin Nephelometric Assay · Traditional | 12/22/1977SE |
| K772247 | Complement C4 Nephelometric AssayDBI · Traditional | 12/22/1977SE |
| K772246 | ALPHA-2-MACROGLOBULIN Nephel. AssayDEB · Traditional | 12/22/1977SE |
| K772245 | Haptoglobin Nephelometric AssayDAD · Traditional | 12/22/1977SE |
| K772128 | Fluorescein ConjugatedDCE · Traditional | 11/22/1977SE |
| K770964 | Goat Antiserum Complement C3 Nephel.DAK · Traditional | 06/24/1977SE |
| K770963 | Goat Antiserum Igm NephelomhtricDFT · Traditional | 06/24/1977SE |
| K770962 | Goat Antiserum Iga NephelometricCZP · Traditional | 06/24/1977SE |
| K770961 | Goat Antiserum Igg NephelometricDEW · Traditional | 06/24/1977SE |
| K770965 | Human Reference Serum · Traditional | 06/22/1977SE |
| K770892 | TSH RadioimmunoassayJLW · Traditional | 06/14/1977SE |
| K770520 | Radioimmunoassay, Quantitipe 125-I-T3CDP · Traditional | 06/03/1977SE |
| K770566 | Immunoelectrophoresis Profile KitJZS · Traditional | 04/27/1977SE |
| K770719 | Immunoelectrofilm KihJZS · Traditional | 04/26/1977SE |
| K770718 | Stain, R-250, Coomassie Brilliant BlueJZS · Traditional | 04/26/1977SE |
| K761321 | Vitamin B12 RadioassayCDD · Traditional | 03/21/1977SE |
| K760396 | Test, Macroglobulin Kit (ALPHA2) · Traditional | 08/26/1976SE |
| K760227 | RadioimmunoassayCDX · Traditional | 07/26/1976SE |