Ncs Diagnostics, Inc.: FDA clearances and approvals
Ncs Diagnostics, Inc. has 15 FDA 510(k) clearances (first 1984, latest 1994), across 8 product codes in 3 review panels. Median 510(k) review time: 26 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 |
|---|---|---|---|
| JSM | Culture Media, Non-Propagating Transport | 7 | 7 |
| LIO | Device, Specimen Collection | 2 | 2 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
| GMP | Antisera, Control For Nontreponemal Tests | 1 | 1 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | 1 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 | 1 |
| JWX | Kit, Screening, Staphylococcus Aureus | 1 | 1 |
Review panels
- Microbiology (13)
- Clinical Chemistry (1)
- Immunology (1)
Most recent Ncs Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943499 | KULTSURE STARSWAB(M240), MODIFICATION | JSM | 1994-11-30 | 170 |
| K943498 | KULTSURE STARSWAB (M210), MODIFICATION | JSM | 1994-11-30 | 170 |
| K882811 | STREPSLIDE | GTY | 1988-10-25 | 110 |
| K881209 | ASO SLIDE TEST | GTQ | 1988-04-12 | 22 |
| K874019 | STAPHSLIDE | JWX | 1987-10-28 | 26 |
| K871404 | KULTSURE | JSM | 1987-04-21 | 13 |
| K870231 | KULTSURE | LIO | 1987-02-04 | 14 |
| K860178 | KULTSURE (CULTURE TRANSPORT) | JSM | 1986-04-04 | 77 |
| K860655 | KULTSURE (CATALOGUE NO. M200) | LIO | 1986-03-06 | 13 |
| K860658 | KULTSURE (CATALOGUE NO. M250) | JSM | 1986-03-04 | 11 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ncs Diagnostics, 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 Ncs Diagnostics, Inc. have?
Ncs Diagnostics, Inc. has 15 FDA 510(k) clearances (first 1984, latest 1994), across 8 product codes in 3 review panels.
How long does FDA take to clear Ncs Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Ncs Diagnostics, Inc.'s cleared 510(k)s is 26 days.
What devices does Ncs Diagnostics, Inc. make?
Its most frequent FDA product codes are JSM (Culture Media, Non-Propagating Transport, 7); LIO (Device, Specimen Collection, 2); DHR (System, Test, Rheumatoid Factor, 1).
Has Ncs Diagnostics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ncs Diagnostics, Inc. Related entities may recall under other names.
Next steps
- See all 15 Ncs Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSM, Ncs Diagnostics, 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.