Nobel Scientific Industries, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Nobel Scientific Industries, Inc.” (first 1976, latest 1986), across 17 product codes in 3 review panels. Median 510(k) review time under this name: 28 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | 3 | 3 |
| JFS | Coulometric, Chloride | 3 | 3 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 | 2 |
| GIF | Diluent, Blood Cell | 2 | 2 |
| CDN | Urease, Photometric, Urea Nitrogen | 1 | 1 |
| CDS | Electrode, Ion Specific, Urea Nitrogen | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
| GGK | Products, Red-Cell Lysing Products | 1 | 1 |
Plus 7 more product codes.
Review panels
- Clinical Chemistry (18)
- Hematology (3)
- Pathology (1)
Most recent Nobel Scientific Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K854717 | NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928 | CEK | 1986-01-14 | 53 |
| K854716 | NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909 | CIC | 1986-01-07 | 46 |
| K854718 | NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926 | CIX | 1985-12-19 | 27 |
| K850944 | NSI LYSING-D REAGENT -4000 ML | GGK | 1985-03-29 | 22 |
| K844782 | NSI ELT-D DILUTING FLUID 4000ML | GIF | 1985-03-05 | 85 |
| K823283 | FLUSHING SOLUTION | — | 1982-12-03 | 29 |
| K812866 | ASTRA REAGENT CONCENTRATE SYSTEM | CGA | 1981-12-17 | 65 |
| K810550 | SILVER ANODE | JFS | 1981-04-08 | 37 |
| K810549 | THERMAL PRINTER PAPER | JJE | 1981-04-08 | 37 |
| K802518 | BUN REAGENT ASTRA 4 & 8 ANALYZERS | CDN | 1980-11-12 | 28 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nobel Scientific Industries, 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.
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.
- Nobel Biocare AB (94 510(k)s)
- Nobel Biocare Uas, Inc. (31 510(k)s)
- Nobel Biocare USA, LLC (9 510(k)s)
- Nobel Biocare Services AG (5 510(k)s)
- Nobel Biocare AG (2 510(k)s)
- Nobel Biocare C/O Medicim NV (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nobel Scientific Industries, Inc.?
FDA lists 23 510(k) clearances under the applicant name “Nobel Scientific Industries, Inc.” (first 1976, latest 1986), across 17 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 Nobel Scientific Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nobel Scientific Industries, Inc. is 28 days.
Which FDA product codes appear under Nobel Scientific Industries, Inc.?
The most frequent FDA product codes under this applicant name are CGA (Glucose Oxidase, Glucose, 3); JFS (Coulometric, Chloride, 3); CGX (Alkaline Picrate, Colorimetry, Creatinine, 2).
Next steps
- See all 23 Nobel Scientific Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CGA, Nobel Scientific Industries, 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.