Medical & Scientific Designs, Inc.: FDA clearances and approvals
Medical & Scientific Designs, Inc. has 14 FDA 510(k) clearances (first 1983, latest 1986), across 12 product codes in 3 review panels. Median 510(k) review time: 48 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 |
|---|---|---|---|
| JJJ | Counter (Beta, Gamma) For Clinical Use | 3 | 3 |
| CDD | Radioassay, Vitamin B12 | 1 | 1 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 | 1 |
| DON | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep. | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
Plus 2 more product codes.
Review panels
- Clinical Chemistry (11)
- Clinical Toxicology (2)
- Immunology (1)
Most recent Medical & Scientific Designs, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K862960 | PHASE II FERRITIN RADIOIMMUNOASSAY KIT | DBF | 1986-08-27 | 22 |
| K853224 | PHASE II B-12/FOLATE KIT | CDD | 1985-10-03 | 63 |
| K840901 | PHASE II FREE T4 KIT | CEC | 1984-04-25 | 57 |
| K840328 | PHASE II HCG KIT | JHI | 1984-04-19 | 85 |
| K834219 | PHASE II CORTISOL KIT | CGR | 1984-02-04 | 61 |
| K833789 | PHASE II THEOPHYLLINE RADIOIMMUNOASSAY | LCA | 1984-01-24 | 85 |
| K832499 | PHASE II TSH KIT | JLW | 1983-09-12 | 47 |
| K832210 | GAMMA PHOTON GAMMA COUNTER | JJJ | 1983-08-24 | 48 |
| K832209 | KINETI COUNT 24 GAMMA COUNTER | JJJ | 1983-08-24 | 48 |
| K831064 | PHASE II T3 RADIOIMMUNOASSAY KIT | CDP | 1983-05-09 | 35 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medical & Scientific Designs, 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 Medical & Scientific Designs, Inc. have?
Medical & Scientific Designs, Inc. has 14 FDA 510(k) clearances (first 1983, latest 1986), across 12 product codes in 3 review panels.
How long does FDA take to clear Medical & Scientific Designs, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Medical & Scientific Designs, Inc.'s cleared 510(k)s is 48 days.
What devices does Medical & Scientific Designs, Inc. make?
Its most frequent FDA product codes are JJJ (Counter (Beta, Gamma) For Clinical Use, 3); CDD (Radioassay, Vitamin B12, 1); CDP (Radioimmunoassay, Total Triiodothyronine, 1).
Has Medical & Scientific Designs, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medical & Scientific Designs, Inc. Related entities may recall under other names.
Next steps
- See all 14 Medical & Scientific Designs, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJJ, Medical & Scientific Designs, 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.