Incstar Corp.: FDA filings under this applicant name
FDA lists 58 510(k) clearances under the applicant name “Incstar Corp.” (first 1987, latest 1997), plus 1 PMA decision, across 24 product codes in 5 review panels. Median 510(k) review time under this name: 91 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 25 | 25 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 3 | 3 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 3 | 3 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 3 | 3 |
| LSE | Epstein-Barr Virus, Other | 3 | 3 |
| GGT | Assay, Erythropoietin | 2 | 2 |
| IGC | Formalin-Saline | 2 | 2 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | 1 |
Plus 14 more product codes.
Review panels
- Immunology (32)
- Microbiology (13)
- Clinical Chemistry (9)
- Hematology (3)
- Pathology (2)
Most recent Incstar Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963289 | INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY | LGD | 1997-05-01 | 253 |
| K963297 | INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560) | LGD | 1996-12-16 | 117 |
| K963296 | INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565) | LGD | 1996-12-16 | 117 |
| K960367 | INCSTAR RUBELLA IGG ELISA ASSAY | LFX | 1996-10-24 | 273 |
| K960358 | INCSTAR RUBELLA IGG FAST ELISA ASSAY | LFX | 1996-10-24 | 273 |
| K960434 | INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530 | LFZ | 1996-10-17 | 260 |
| K953567 | INCSTAR 25-HYDROXYVITMIN D 1251 RIA | MRG | 1996-09-25 | 422 |
| K955363 | INCSTAR HSZ I/II IGG ELISA ASSAY | IGC | 1996-07-24 | 245 |
| K955362 | INCSTAR HSV I/II IGG FAST ELISA ASSAY | IGC | 1996-07-24 | 245 |
| K955361 | INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY | LFZ | 1996-07-22 | 243 |
48 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P790032 | PMA | GAMMA DAB (125I) AFP RIA KIT | 1986-04-30 |
Recalls
openFDA lists no recalls under a recalling firm named Incstar Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Incstar Corp.?
FDA lists 58 510(k) clearances under the applicant name “Incstar Corp.” (first 1987, latest 1997), plus 1 PMA decision, across 24 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Incstar Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Incstar Corp. is 91 days.
Which FDA product codes appear under Incstar Corp.?
The most frequent FDA product codes under this applicant name are DHB (System, Test, Radioallergosorbent (Rast) Immunological, 25); CEW (Radioimmunoassay, Parathyroid Hormone, 3); LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus, 3).
Next steps
- See all 58 Incstar Corp. clearances with predicates and recalls
- Run predicate analysis for product code DHB, Incstar Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.