Syn-Kit, Inc.: FDA clearances and approvals
Syn-Kit, Inc. has 34 FDA 510(k) clearances (first 1980, latest 1986), across 21 product codes in 4 review panels. Median 510(k) review time: 84 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 |
|---|---|---|---|
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 11 | 11 |
| DCN | System, Test, C-Reactive Protein | 2 | 2 |
| DHR | System, Test, Rheumatoid Factor | 2 | 2 |
| KHE | Reagent, Occult Blood | 2 | 2 |
| CDO | Acid, Uric, Uricase (U.V.) | 1 | 1 |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 | 1 |
| GHH | Fibrin Split Products | 1 | 1 |
| GMM | Antigens, Iha, Toxoplasma Gondii | 1 | 1 |
Plus 11 more product codes.
Review panels
- Clinical Chemistry (21)
- Microbiology (6)
- Immunology (4)
- Hematology (3)
Most recent Syn-Kit, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861098 | SEROIDEN STREPTO KIT 'EIKEN' | GTZ | 1986-08-12 | 141 |
| K861631 | SLIDE CULTURE U 'EIKEN' | JXA | 1986-06-10 | 42 |
| K854819 | CPR SLIDE EIKEN | DCN | 1986-02-26 | 85 |
| K854820 | RA 80 EIKEN | DHR | 1986-01-17 | 45 |
| K853276 | ASO SLIDE EIKEN | GTQ | 1985-08-20 | 15 |
| K843760 | UROPAPER EIKEN G | JIL | 1984-12-18 | 84 |
| K843759 | UROPAPER EIKEN HAG | JIL | 1984-12-18 | 84 |
| K843758 | UROPAPER EIKEN GK | JIL | 1984-12-18 | 84 |
| K843757 | UROPAPER EIKEN AG | JIL | 1984-12-18 | 84 |
| K843756 | UROPAPER EIKEN 5 | JIL | 1984-12-18 | 84 |
24 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Syn-Kit, 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 Syn-Kit, Inc. have?
Syn-Kit, Inc. has 34 FDA 510(k) clearances (first 1980, latest 1986), across 21 product codes in 4 review panels.
How long does FDA take to clear Syn-Kit, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Syn-Kit, Inc.'s cleared 510(k)s is 84 days.
What devices does Syn-Kit, Inc. make?
Its most frequent FDA product codes are JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative), 11); DCN (System, Test, C-Reactive Protein, 2); DHR (System, Test, Rheumatoid Factor, 2).
Has Syn-Kit, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Syn-Kit, Inc. Related entities may recall under other names.
Next steps
- See all 34 Syn-Kit, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JIL, Syn-Kit, 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.