Starplex Scientific, Inc.: FDA clearances and approvals
Starplex Scientific, Inc. has 11 FDA 510(k) clearances (first 1992, latest 2003), across 6 product codes in 3 review panels. Median 510(k) review time: 139 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 |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 5 | 5 |
| JSM | Culture Media, Non-Propagating Transport | 2 | 2 |
| DJC | Thin Layer Chromatography, Methamphetamine | 1 | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| JSL | Culture Media, Anaerobic Transport | 1 | 1 |
| LIO | Device, Specimen Collection | 1 | 1 |
Review panels
Most recent Starplex Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032246 | MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM | JSM | 2003-08-13 | 22 |
| K022388 | STARTOX DRUG OF ABUSE SCREENING TEST (4) | DJC | 2003-02-27 | 219 |
| K021006 | STARTOX DRUG OF ABUSE SCREENING TEST | DKZ | 2002-06-10 | 74 |
| K962843 | MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM | JSM | 1996-09-18 | 58 |
| K960997 | STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM | LIO | 1996-04-03 | 22 |
| K944847 | KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM | JSL | 1995-02-16 | 139 |
| K924364 | VACUPLUS TUBES WITH GREY STOPPERS | JKA | 1993-03-01 | 185 |
| K924362 | VACUPLUS TUBES WITH LAVANDER STOPPERS | JKA | 1993-03-01 | 185 |
| K924361 | VACUPLUS TUBES WITH GREEN STOPPERS | JKA | 1993-03-01 | 185 |
| K924363 | VACUPLUS(R) STAR-SEP(TM) | JKA | 1993-02-08 | 164 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Starplex Scientific, 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 Starplex Scientific, Inc. have?
Starplex Scientific, Inc. has 11 FDA 510(k) clearances (first 1992, latest 2003), across 6 product codes in 3 review panels.
How long does FDA take to clear Starplex Scientific, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Starplex Scientific, Inc.'s cleared 510(k)s is 139 days.
What devices does Starplex Scientific, Inc. make?
Its most frequent FDA product codes are JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 5); JSM (Culture Media, Non-Propagating Transport, 2); DJC (Thin Layer Chromatography, Methamphetamine, 1).
Has Starplex Scientific, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Starplex Scientific, Inc. Related entities may recall under other names.
Next steps
- See all 11 Starplex Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JKA, Starplex Scientific, 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.