Incstar Corp.
Stillwater, MN, US
Incstar Corp. appears in FDA device records in Stillwater, MN. FDA records list 58 510(k) clearances between and , 4 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 58
- PMA records
- 4
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 58FDA records hold 58 510(k) clearances for Incstar Corp. between 1987 and 1997. The busiest year on record is 1987, with 17. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 17 |
| 1988 | 11 |
| 1989 | 2 |
| 1990 | 3 |
| 1992 | 5 |
| 1993 | 1 |
| 1994 | 4 |
| 1995 | 4 |
| 1996 | 10 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K963289 | INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY | LGD | Substantially Equivalent | |
| K963297 | INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560) | LGD | Substantially Equivalent | |
| K963296 | INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565) | LGD | Substantially Equivalent | |
| K960367 | INCSTAR RUBELLA IGG ELISA ASSAY | LFX | Substantially Equivalent | |
| K960358 | INCSTAR RUBELLA IGG FAST ELISA ASSAY | LFX | Substantially Equivalent | |
| K960434 | INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530 | LFZ | Substantially Equivalent | |
| K953567 | INCSTAR 25-HYDROXYVITMIN D 1251 RIA | MRG | Substantially Equivalent | |
| K955363 | INCSTAR HSZ I/II IGG ELISA ASSAY | IGC | Substantially Equivalent | |
| K955362 | INCSTAR HSV I/II IGG FAST ELISA ASSAY | IGC | Substantially Equivalent | |
| K955361 | INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY | LFZ | Substantially Equivalent | |
| K955360 | INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY | LFZ | Substantially Equivalent | |
| K951639 | COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) | DAE | Substantially Equivalent | |
| K946158 | INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT | LLM | Substantially Equivalent | |
| K946159 | INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT | LSE | Substantially Equivalent | |
| K946157 | INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT | LSE | Substantially Equivalent | |
| K941168 | CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT | CHP | Substantially Equivalent | |
| K940271 | INCSTAR ACTH IRMA | CKG | Substantially Equivalent | |
| K935075 | SPQ CRP CONTROL LEVEL II | DCN | Substantially Equivalent | |
| K934966 | SPQ PAL CONTROL LEVEL II | DDS | Substantially Equivalent | |
| K934521 | SPQ MALB CONTROL LEVEL II | JJX | Substantially Equivalent | |
| K921628 | EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA | LSE | Substantially Equivalent | |
| K921616 | CMV-VUE(TM) CMV ANTIGEN DETECTION KIT | LIN | Substantially Equivalent for Some Indications | |
| K921629 | N-TACT(R) PTH SP KIT | CEW | Substantially Equivalent | |
| K915235 | CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT | CDX | Substantially Equivalent | |
| K915570 | GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT | CDZ | Substantially Equivalent | |
| K902639 | EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA) | GGT | Substantially Equivalent | |
| K901711 | PTH-MM II 125I RADIOIMMUNOASSAY (RIA) | CEW | Substantially Equivalent | |
| K900939 | SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.) | KQJ | Substantially Equivalent | |
| K893393 | EPO-TRAC BY RADIOIMMUNOASSAY (RIA) | GGT | Substantially Equivalent | |
| K895496 | BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA | JZG | Substantially Equivalent | |
| K875110 | HOUSE DUST; HOLLISTER-STIER (H/S) ALLERGEN DISC | DHB | Substantially Equivalent | |
| K880221 | INCSTAR'S PIGWEED ALLERGEN DISC | DHB | Substantially Equivalent | |
| K880168 | INCSTAR'S BIRCH ALLERGEN DISC | DHB | Substantially Equivalent | |
| K874883 | WALNUT ALLERGEN DISC | DHB | Substantially Equivalent | |
| K874540 | MARSH ELDER ALLERGEN DISC | DHB | Substantially Equivalent | |
| K880567 | WHITE ASH ALLERGEN DISC | DHB | Substantially Equivalent | |
| K880415 | MESQUITE ALLERGEN DISC | DHB | Substantially Equivalent | |
| K880187 | INCSTAR'S DANDELION ALLERGEN DISC | DHB | Substantially Equivalent | |
| K875163 | GOLDENROD ALLERGEN DISC | DHB | Substantially Equivalent | |
| K875274 | TOTAL IGE IMMUNO RESPONSE TEST (IRT(R)) | DHB | Substantially Equivalent | |
| K874541 | RRT TOTAL IGE TEST KIT | DGC | Substantially Equivalent | |
| K874440 | LIVE OAK ALLERGEN DISC | DHB | Substantially Equivalent | |
| K874299 | N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA) | CEW | Substantially Equivalent | |
| K874150 | JOHNSON GRASS ALLERGEN DISC | DHB | Substantially Equivalent | |
| K874149 | FALSE RAGWEED ALLERGEN DISC | DHB | Substantially Equivalent | |
| K873969 | GIANT RAGWEED ALLERGEN DISC | DHB | Substantially Equivalent | |
| K873814 | IGE IMMUNO RESPONSE TEST (IRT) COMP. FOR MOD. RAST | DHB | Substantially Equivalent | |
| K873770 | BERMUDA GRASS ALLERGEN DISC | DHB | Substantially Equivalent | |
| K873648 | BAHIA ALLERGEN DISC | DHB | Substantially Equivalent | |
| K873676 | IGE IMMUNO RESPONSE TEST (IRT) CALIBRATOR UNIT | DHB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LINAntisera, Conjugated Fluorescent, Cytomegalovirus
- GGTAssay, Erythropoietin
- DAEComplement C9, Antigen, Antiserum, Control
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- LSEEpstein-Barr Virus, Other
- IGCFormalin-Saline
- DGCIge, Antigen, Antiserum, Control
- LOKKit, Test, Alpha-Fetoprotein For Neural Tube Defects
- JZWNephelometer
- DDSPrealbumin, Fitc, Antigen, Antiserum, Control
- CKGRadioimmunoassay, Acth
- CHPRadioimmunoassay, Estradiol
- CEWRadioimmunoassay, Parathyroid Hormone
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- CDXRadioimmunoassay, Total Thyroxine
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- KQJSystem, Fibrinogen Determination
- JZGSystem, Test, Beta-2-Microglobulin Immunological
- DCNSystem, Test, C-Reactive Protein
- DHBSystem, Test, Radioallergosorbent (Rast) Immunological
- MRGSystem, Test, Vitamin D
- LLMTest, Antigen, Nuclear, Epstein-Barr Virus
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain