Immunoprobe, Inc.: FDA clearances and approvals
Immunoprobe, Inc. has 14 FDA 510(k) clearances (first 1994, latest 1997), across 6 product codes in 2 review panels. Median 510(k) review time: 191 days.
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 |
|---|---|---|---|
| MID | System, Test, Anticardiolipin Immunological | 5 | 5 |
| JNL | Immunochemical, Thyroglobulin Autoantibody | 4 | 4 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | 2 |
| GOD | Antigens, Cf (Including Cf Control), Adenovirus 1-33 | 1 | 1 |
| LJZ | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | 1 | 1 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 1 | 1 |
Review panels
- Immunology (11)
- Microbiology (3)
Most recent Immunoprobe, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972406 | ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM | GOD | 1997-12-22 | 179 |
| K971393 | MYCOPLASMA IGG ELISA TEST SYSTEM | LJZ | 1997-07-14 | 96 |
| K961765 | MPO ELISA TEST SYSTEM | MOB | 1996-08-19 | 104 |
| K961764 | PR-3 ELISA TEST SYSTEM | MOB | 1996-08-19 | 104 |
| K951549 | EBNA IGG EIA TEST SYSTEM | LLM | 1996-04-29 | 391 |
| K952523 | CARDIOLIPIN IGG EIA TEST KIT | MID | 1996-02-09 | 253 |
| K952522 | CARDIOLIPIN IGA EIA TEST SYSTEM | MID | 1996-02-09 | 253 |
| K952521 | CARDIOLIPIN IGM EIA TEST SYSTEM | MID | 1996-02-09 | 253 |
| K951364 | MICROSOMAL EIA TEST KIT | JNL | 1995-11-20 | 241 |
| K951362 | THYROGLOBULIN EIA TEST KIT | JNL | 1995-11-20 | 241 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Immunoprobe, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Immunoprobe, Inc. have?
Immunoprobe, Inc. has 14 FDA 510(k) clearances (first 1994, latest 1997), across 6 product codes in 2 review panels.
How long does FDA take to clear Immunoprobe, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Immunoprobe, Inc.'s cleared 510(k)s is 191 days.
What devices does Immunoprobe, Inc. make?
Its most frequent FDA product codes are MID (System, Test, Anticardiolipin Immunological, 5); JNL (Immunochemical, Thyroglobulin Autoantibody, 4); MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca), 2).
Has Immunoprobe, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Immunoprobe, Inc. Related entities may recall under other names.
Next steps
- See all 14 Immunoprobe, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MID, Immunoprobe, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.