Immunostics Inc.,: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Immunostics Inc.,” (first 1984, latest 2023), across 13 product codes in 4 review panels. Median 510(k) review time under this name: 65 days. Since 2017 the median was 174 days, against 161 days for all cleared 510(k)s in the same product codes. 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 | 4 | 146 |
| 2018 | 1 | 84 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 457 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Immunostics Inc., took a median 174 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 161 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KHE | Reagent, Occult Blood | 7 | 7 |
| DHR | System, Test, Rheumatoid Factor | 3 | 3 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 3 | 3 |
| GKR | System, Hemoglobin, Automated | 2 | 2 |
| KTN | System, Test, Infectious Mononucleosis | 2 | 2 |
| DCN | System, Test, C-Reactive Protein | 1 | 1 |
| DHC | System, Test, Systemic Lupus Erythematosus | 1 | 1 |
| GNC | Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. | 1 | 1 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
Plus 3 more product codes.
Review panels
- Hematology (10)
- Clinical Chemistry (5)
- Immunology (5)
- Microbiology (5)
Most recent Immunostics Inc., 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221817 | ALFIS Vitamin D, ALFIS-3 Analyzer | MRG | 2023-09-22 | 457 |
| K182298 | hemochroma PLUS System | GKR | 2018-11-16 | 84 |
| K163465 | hemochroma PLUS System | GKR | 2017-09-08 | 270 |
| K163225 | AFIAS iFOB with AFIAS-50 | OOX | 2017-08-08 | 264 |
| K171484 | hema-screen SPECIFIC Gold | KHE | 2017-06-14 | 23 |
| K163554 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test | KHE | 2017-01-17 | 29 |
| K102664 | HEMA SCREEN ER | KHE | 2011-01-28 | 135 |
| K060463 | HEMA SCREEN SPECIFIC IFOBT | KHE | 2006-06-06 | 104 |
| K041728 | HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE | JHI | 2004-08-11 | 47 |
| K031490 | RUBELLACOL | LQN | 2003-07-16 | 65 |
15 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2023-08-25.
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 Immunostics Inc.,?
FDA lists 25 510(k) clearances under the applicant name “Immunostics Inc.,” (first 1984, latest 2023), across 13 product codes in 4 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 Immunostics Inc.,?
The median time from FDA receipt to decision across 510(k)s cleared under the name Immunostics Inc., is 65 days. Since 2017: 174 days, versus 161 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Immunostics Inc.,?
The most frequent FDA product codes under this applicant name are KHE (Reagent, Occult Blood, 7); DHR (System, Test, Rheumatoid Factor, 3); JHJ (Agglutination Method, Human Chorionic Gonadotropin, 3).
Next steps
- See all 25 Immunostics Inc., clearances with predicates and recalls
- Run predicate analysis for product code KHE, Immunostics Inc.,'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.