Incstar Corp.
Medical device manufacturer in Stillwater, MN.
58510(k) clearances
1PMA approvals
0recalls
Device types
- DHB System, Test, Radioallergosorbent (Rast)… 25
- CEW Radioimmunoassay, Parathyroid Hormone 3
- LFZ Enzyme Linked Immunoabsorbent Assay… 3
- LGD Enzyme Linked Immunoabsorbent Assay… 3
- LSE Epstein-Barr Virus, Other 3
- LFX Enzyme Linked Immunoabsorbent Assay, Rubella 2
- IGC Formalin-Saline 2
- GGT Assay, Erythropoietin 2
- CDZ Radioimmunoassay, Testosterones And… 1
- CDX Radioimmunoassay, Total Thyroxine 1
- LIN Antisera, Conjugated Fluorescent… 1
- KQJ System, Fibrinogen Determination 1
- JJX Single (Specified) Analyte Controls… 1
- DDS Prealbumin, Fitc, Antigen, Antiserum, Control 1
- DCN System, Test, C-Reactive Protein 1
- CKG Radioimmunoassay, Acth 1
- CHP Radioimmunoassay, Estradiol 1
- LLM Test, Antigen, Nuclear, Epstein-Barr Virus 1
- JZG System, Test, Beta-2-Microglobulin… 1
- DGC Ige, Antigen, Antiserum, Control 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K963289 | Incstar Toxoplasma Igm Capture Elisa AssayLGD · Traditional | 05/01/1997SE |
| K963297 | Incstar Toxoplasma Igg Fast Elisa Assay (CAT.#7560)LGD · Traditional | 12/16/1996SE |
| K963296 | Incstar Toxoplasma Igg Alisa Assay (CAT.#7565)LGD · Traditional | 12/16/1996SE |
| K960367 | Incstar Rubella Igg Elisa AssayLFX · Traditional | 10/24/1996SE |
| K960358 | Incstar Rubella Igg Fast Elisa AssayLFX · Traditional | 10/24/1996SE |
| K960434 | Incstar Cytomegalovirus Igm Capture Elisa Assay Model 8530LFZ · Traditional | 10/17/1996SE |
| K953567 | Incstar 25-HYDROXYVITMIN D 1251 RiaMRG · Traditional | 09/25/1996SE |
| K955363 | Incstar HSZ I/Ii Igg Elisa AssayIGC · Traditional | 07/24/1996SE |
| K955362 | Incstar HSV I/Ii Igg Fast Elisa AssayIGC · Traditional | 07/24/1996SE |
| K955361 | Incstar Cytomegalovirus Igg Elisa AssayLFZ · Traditional | 07/22/1996SE |
| K955360 | Incstar Cytomegalovirus Igg Fast Elisa AssayLFZ · Traditional | 07/22/1996SE |
| K951639 | Complement Activation Eia Test System (Cae)DAE · Traditional | 10/13/1995SE |
| K946158 | Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa KitLLM · Traditional | 06/09/1995SE |
| K946159 | Incstar Epstein-Barr Viral Capsid Antigen (Vca) Igg Elisa KitLSE · Traditional | 06/07/1995SE |
| K946157 | Incstar Epstein-Barr Viral Capsid Antigen (Vca) LGM Elisa KitLSE · Traditional | 06/07/1995SE |
| K941168 | Clinical Assays Gammacoat [125] Estradiol Radioimmunoassay KitCHP · Traditional | 09/07/1994SE |
| K940271 | Incstar Acth IrmaCKG · Traditional | 08/02/1994SE |
| K935075 | SPQ CRP Control Level IIDCN · Traditional | 01/11/1994SE |
| K934966 | SPQ Pal Control Level IIDDS · Traditional | 01/11/1994SE |
| K934521 | SPQ Malb Control Level IIJJX · Traditional | 11/26/1993SE |
| K921628 | Epstein-Barr Vir Early Anti Diff Igg Clin-ElisaLSE · Traditional | 09/14/1992SE |
| K921616 | Cmv-Vue(Tm) CMV Antigen Detection KitLIN · Traditional | 08/11/1992SN |
| K921629 | N-Tact(R) PTH SP KitCEW · Traditional | 05/14/1992SE |
| K915235 | Clinical Assays Gamma Coat Free T4 Radioimm. KitCDX · Traditional | 01/28/1992SE |
| K915570 | Gamma Coat Assay Testosterone Radioimmunoassay KitCDZ · Traditional | 01/27/1992SE |
| K902639 | Epo-Trac(Tm) 125I Radioimmunoassay (Ria)GGT · Traditional | 08/22/1990SE |
| K901711 | Pth-Mm II 125I Radioimmunoassay (Ria)CEW · Traditional | 07/16/1990SE |
| K900939 | SPQ Test System II for Fib (Serum Protein Quanti.)KQJ · Traditional | 05/16/1990SE |
| K893393 | Epo-Trac by Radioimmunoassay (Ria)GGT · Traditional | 11/21/1989SE |
| K895496 | BETA2 M-Trac by Enzyme Bead-Based Immunoassay EiaJZG · Traditional | 10/17/1989SE |
| K875110 | House Dust; Hollister-Stier (H/S) Allergen DiscDHB · Traditional | 06/14/1988SE |
| K880221 | Incstar's Pigweed Allergen DiscDHB · Traditional | 05/11/1988SE |
| K880168 | Incstar's Birch Allergen DiscDHB · Traditional | 05/11/1988SE |
| K874883 | Walnut Allergen DiscDHB · Traditional | 05/11/1988SE |
| K874540 | Marsh Elder Allergen DiscDHB · Traditional | 05/11/1988SE |
| K880567 | White Ash Allergen DiscDHB · Traditional | 04/21/1988SE |
| K880415 | Mesquite Allergen DiscDHB · Traditional | 04/21/1988SE |
| K880187 | Incstar's Dandelion Allergen DiscDHB · Traditional | 04/21/1988SE |
| K875163 | Goldenrod Allergen DiscDHB · Traditional | 04/21/1988SE |
| K875274 | Total Ige Immuno Response Test (Irt(R))DHB · Traditional | 02/17/1988SE |
| K874541 | RRT Total Ige Test KitDGC · Traditional | 02/17/1988SE |
| K874440 | Live Oak Allergen DiscDHB · Traditional | 11/25/1987SE |
| K874299 | N-Tact PTH by Immunoradiometric Assay (Irma)CEW · Traditional | 11/23/1987SE |
| K874150 | Johnson Grass Allergen DiscDHB · Traditional | 11/04/1987SE |
| K874149 | False Ragweed Allergen DiscDHB · Traditional | 11/04/1987SE |
| K873969 | Giant Ragweed Allergen DiscDHB · Traditional | 11/04/1987SE |
| K873814 | Ige Immuno Response Test (Irt) Comp. for Mod. RastDHB · Traditional | 10/20/1987SE |
| K873770 | Bermuda Grass Allergen DiscDHB · Traditional | 10/20/1987SE |
| K873648 | Bahia Allergen DiscDHB · Traditional | 10/08/1987SE |
| K873676 | Ige Immuno Response Test (Irt) Calibrator UnitDHB · Traditional | 10/07/1987SE |
| K873486 | Red Top Allergen DiscDHB · Traditional | 10/07/1987SE |
| K873407 | RRT System Laser Reflectometer AnalyzerJZW · Traditional | 09/23/1987SE |
| K873406 | RRT Short Ragweed Test KitDHB · Traditional | 09/23/1987SE |
| K871684 | Alternaria Tenuis Allergen DiscDHB · Traditional | 07/16/1987SE |
| K871723 | Sweet Vernal Allergen DiscDHB · Traditional | 07/13/1987SE |
| K871660 | Western Ragweed Allergen DiscDHB · Traditional | 05/14/1987SE |
| K870597 | D. Farinae Allergen DiscDHB · Traditional | 03/04/1987SE |
| K870264 | Cat Epithelium Allergen DiscDHB · Traditional | 02/13/1987SE |
PMA approvals
- P790032 Gamma Dab (125I) Afp Ria Kit · 04/30/1986 · 3 supplements