Nichols Institute: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Nichols Institute” (first 1990, latest 1996), across 12 product codes in 3 review panels. Median 510(k) review time under this name: 105 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 |
|---|---|---|---|
| CFL | Radioimmunoassay, Human Growth Hormone | 2 | 2 |
| GGT | Assay, Erythropoietin | 2 | 2 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 | 1 |
| CKG | Radioimmunoassay, Acth | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| JNL | Immunochemical, Thyroglobulin Autoantibody | 1 | 1 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 1 | 1 |
Plus 2 more product codes.
Review panels
- Clinical Chemistry (10)
- Immunology (3)
- Hematology (2)
Most recent Nichols Institute 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952559 | ERYTHROPOIETIN IMMUNOASSAY KIT | GGT | 1996-05-29 | 362 |
| K952505 | INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) | CFL | 1995-07-03 | 33 |
| K946247 | IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 | CFL | 1995-06-23 | 183 |
| K950524 | NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY | JKC | 1995-05-15 | 105 |
| K932650 | ERYTHROPOIETIN IMMUNOASSAY KIT | GGT | 1994-03-11 | 282 |
| K931600 | CHEMILUMINESCENCE FREE T3 IMMUNOASSAY | CDP | 1993-09-08 | 160 |
| K931777 | APO A-1 CHEMILUMINESCENCE ASSAY | MSJ | 1993-08-16 | 129 |
| K931601 | CHEMILUMINESCENCE DHEA-S IMMUNOASSAY | JKC | 1993-07-27 | 117 |
| K926396 | ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT | CKG | 1993-07-27 | 218 |
| K931311 | THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT | JZO | 1993-05-14 | 60 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nichols Institute.
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 Diagnostics (68 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nichols Institute?
FDA lists 15 510(k) clearances under the applicant name “Nichols Institute” (first 1990, latest 1996), across 12 product codes in 3 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?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nichols Institute is 105 days.
Which FDA product codes appear under Nichols Institute?
The most frequent FDA product codes under this applicant name are CFL (Radioimmunoassay, Human Growth Hormone, 2); GGT (Assay, Erythropoietin, 2); JKC (Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate), 2).
Next steps
- See all 15 Nichols Institute clearances with predicates and recalls
- Run predicate analysis for product code CFL, Nichols Institute'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.