Nichols Institute Diagnostics: FDA filings under this applicant name
FDA lists 68 510(k) clearances under the applicant name “Nichols Institute Diagnostics” (first 1977, latest 2005), across 33 product codes in 6 review panels. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| CEW | Radioimmunoassay, Parathyroid Hormone | 13 | 13 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 4 | 4 |
| CFL | Radioimmunoassay, Human Growth Hormone | 4 | 4 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 3 | 3 |
| CGR | Radioimmunoassay, Cortisol | 3 | 3 |
| CKG | Radioimmunoassay, Acth | 3 | 3 |
| JKR | Radioimmunoassay, Calcitonin | 3 | 3 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 3 | 3 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 2 | 2 |
| CEC | Radioimmunoassay, Free Thyroxine | 2 | 2 |
Plus 23 more product codes.
Review panels
- Clinical Chemistry (55)
- Immunology (8)
- Clinical Toxicology (2)
- Hematology (1)
- Microbiology (1)
- Pathology (1)
Most recent Nichols Institute Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050784 | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | CJM | 2005-06-01 | 65 |
| K042676 | NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY | DHA | 2004-12-17 | 79 |
| K042689 | NICHOLS ADVANTAGE CORTISOL | CGR | 2004-12-09 | 71 |
| K040813 | NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022 | CEW | 2004-06-08 | 70 |
| K033727 | NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY | CEW | 2004-04-22 | 146 |
| K033302 | NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 | CEW | 2004-01-26 | 104 |
| K032188 | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | CJM | 2003-07-31 | 14 |
| K022356 | NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY | LYR | 2002-10-25 | 98 |
| K022472 | PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84) | CEW | 2002-10-09 | 75 |
| K013992 | NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY | CEW | 2001-12-13 | 9 |
58 earlier clearances. See the full list in Caduvo.
Recalls
10 product recalls in 9 recall events; 0 initiated in the last five years. Most recent: 2005-09-30.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Nichols Institute (15 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nichols Institute Diagnostics?
FDA lists 68 510(k) clearances under the applicant name “Nichols Institute Diagnostics” (first 1977, latest 2005), across 33 product codes in 6 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 Nichols Institute Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nichols Institute Diagnostics is 70 days.
Which FDA product codes appear under Nichols Institute Diagnostics?
The most frequent FDA product codes under this applicant name are CEW (Radioimmunoassay, Parathyroid Hormone, 13); CEP (Radioimmunoassay, Luteinizing Hormone, 4); CFL (Radioimmunoassay, Human Growth Hormone, 4).
Next steps
- See all 68 Nichols Institute Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code CEW, Nichols Institute Diagnostics'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.