Monobind: FDA clearances and approvals
Monobind has 23 FDA 510(k) clearances (first 1977, latest 2018), across 14 product codes in 3 review panels. Median 510(k) review time: 43 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 101 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Monobind's cleared 510(k)s took a median 101 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 149 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | 3 | 3 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 3 | 3 |
| CDX | Radioimmunoassay, Total Thyroxine | 2 | 2 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 2 | 2 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 2 | 2 |
| KHQ | Radioassay, Triiodothyronine Uptake | 2 | 2 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 2 | 2 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
Plus 4 more product codes.
Review panels
- Clinical Chemistry (20)
- Immunology (2)
- Clinical Toxicology (1)
Most recent Monobind 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181017 | Free Testosterone AccuBind ELISA Test System | CDZ | 2018-07-20 | 101 |
| K063437 | ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 | JLW | 2008-04-04 | 507 |
| K030860 | ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 | KLI | 2003-08-22 | 157 |
| K020548 | FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 | CEC | 2002-04-05 | 45 |
| K980088 | T-UPTAKE MICROPLATE EIA | KHQ | 1998-02-04 | 26 |
| K972720 | FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) | CGJ | 1997-09-02 | 43 |
| K971835 | ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA | DDC | 1997-07-03 | 45 |
| K971834 | ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA | JNL | 1997-07-03 | 45 |
| K971921 | PROLACTIN (PRL) HORMONE MICROPLATE ELISA | CFT | 1997-06-24 | 32 |
| K971780 | THYROTROPIN(TSH) ELISA | JLW | 1997-06-24 | 41 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Monobind.
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 Monobind have?
Monobind has 23 FDA 510(k) clearances (first 1977, latest 2018), across 14 product codes in 3 review panels.
How long does FDA take to clear Monobind's 510(k)s?
The median time from FDA receipt to decision across Monobind's cleared 510(k)s is 43 days.
What devices does Monobind make?
Its most frequent FDA product codes are CDP (Radioimmunoassay, Total Triiodothyronine, 3); JLW (Radioimmunoassay, Thyroid-Stimulating Hormone, 3); CDX (Radioimmunoassay, Total Thyroxine, 2).
Has Monobind had device recalls?
openFDA lists no recalls under a recalling firm name matching Monobind. Related entities may recall under other names.
Next steps
- See all 23 Monobind clearances with predicates and recalls
- Run predicate analysis for product code CDP, Monobind'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.