Immulok, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Immulok, Inc.” (first 1981, latest 1983), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 44 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 |
|---|---|---|---|
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 4 | 4 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | 2 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| DFH | Kappa, Antigen, Antiserum, Control | 1 | 1 |
| DFZ | Igg (Gamma Chain Specific), Antigen, Antiserum, Control | 1 | 1 |
| IEG | Table, Slide Warming | 1 | 1 |
| JTW | System, Transport, Aerobic | 1 | 1 |
| LIN | Antisera, Conjugated Fluorescent, Cytomegalovirus | 1 | 1 |
| LJK | Antisera, If, Toxoplasma Gondii | 1 | 1 |
| LKH | Antisera, Immunoperoxidase, Chlamydia Spp. | 1 | 1 |
Plus 1 more product codes.
Review panels
- Microbiology (9)
- Immunology (4)
- Clinical Chemistry (1)
- Pathology (1)
Most recent Immulok, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K830971 | HERPES SIMPLEX VIRUS TYPING REAGENTS | GQL | 1983-06-30 | 94 |
| K830342 | CULUTURE SET CHLAMYDIA ISOLATION AND | LKI | 1983-05-04 | 92 |
| K830250 | CVT VIRAL TRANSPORTS | JTW | 1983-02-28 | 34 |
| K823304 | RIASET PROLACTIN RIA KIT | CFT | 1982-12-22 | 47 |
| K822785 | FLUOROSET IMMUNOFLUORESCENT ANTIBODY | GQL | 1982-11-29 | 76 |
| K823055 | FLOUROSET IMMUNOFLUORESCENT ANTIBODY | DHN | 1982-11-05 | 18 |
| K822606 | CYTOMEGALOVIRUS ANTOBODY IGG | LIN | 1982-11-01 | 66 |
| K822605 | TOXOPLASMA GONDII ANTIBODY IGG | LJK | 1982-10-27 | 61 |
| K822607 | ANTINUCLEAR ANTOBODY CELL SUBSTRATE | DHN | 1982-09-17 | 21 |
| K821567 | IMMULOK CULTURESET | GQL | 1982-06-25 | 31 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Immulok, Inc..
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 Immulok, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Immulok, Inc.” (first 1981, latest 1983), across 11 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 Immulok, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Immulok, Inc. is 44 days.
Which FDA product codes appear under Immulok, Inc.?
The most frequent FDA product codes under this applicant name are GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2, 4); DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, 2); CFT (Radioimmunoassay, Prolactin (Lactogen), 1).
Next steps
- See all 15 Immulok, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GQL, Immulok, 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.