# Incstar Corp.

- Location (FDA's records): Stillwater, MN
- FDA decisions: 59 (1986–1997): 58 510(k) clearances and 1 original PMA approval
- Product codes: DHB (25), LFZ (3), CEW (3), LSE (3), LGD (3), LFX (2), GGT (2), IGC (2), MRG (1), DGC (1), LIN (1), DDS (1)
- Predicates its devices cite: 8 (0 its own); citations of its devices by later devices: 10 (0 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Clinical Sciences, Inc.: 4 (https://510kreport.com/company/clinical-sciences)
- Gull Laboratories, Inc.: 3 (https://510kreport.com/company/gull-laboratories)
- Mercia Diagnostics, Ltd.: 1 (https://510kreport.com/company/mercia-diagnostics)

## Firms that cite its devices most
- DiaSorin, Inc.: 6 (https://510kreport.com/company/diasorin)
- Digene Corp.: 1 (https://510kreport.com/company/digene)
- Biotest Diagnostics Corp.: 1 (https://510kreport.com/company/biotest-diagnostics)
- Diagnostic Products Corp.: 1 (https://510kreport.com/company/diagnostic-products)
- Bio-Rad Laboratories, Inc.: 1 (https://510kreport.com/company/bio-rad-laboratories)

## Its most-cited devices
- K946157: Incstar Epstein-Barr Viral Capsid Antigen (Vca) LGM Elisa Kit (1995), cited by 2
- K946158: Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa Kit (1995), cited by 2
- K902639: Epo-Trac (TM) 125I Radioimmunoassay (Ria) (1990), cited by 1
- K953567: Incstar 25-Hydroxyvitmin D 1251 Ria (1996), cited by 1
- K921616: CMV-Vue (TM) CMV Antigen Detection Kit (1992), cited by 1
- K946159: Incstar Epstein-Barr Viral Capsid Antigen (Vca) Igg Elisa Kit (1995), cited by 1

## Recent decisions
- K963289: Incstar Toxoplasma Igm Capture Elisa Assay (May 1, 1997)
- K963296: Incstar Toxoplasma Igg Alisa Assay (Cat.#7565) (Dec 16, 1996)
- K963297: Incstar Toxoplasma Igg Fast Elisa Assay (Cat.#7560) (Dec 16, 1996)
- K960367: Incstar Rubella Igg Elisa Assay (Oct 24, 1996)
- K960358: Incstar Rubella Igg Fast Elisa Assay (Oct 24, 1996)
- K960434: Incstar Cytomegalovirus Igm Capture Elisa Assay Model 8530 (Oct 17, 1996)
- K953567: Incstar 25-Hydroxyvitmin D 1251 Ria (Sep 25, 1996)
- K955363: Incstar HSZ I/II Igg Elisa Assay (Jul 24, 1996)

Source page: https://510kreport.com/company/incstar