Shaban Mfg. Co.: FDA filings under this applicant name
FDA lists 35 510(k) clearances under the applicant name “Shaban Mfg. Co.” (first 1982, latest 1985), across 13 product codes in 3 review panels. Median 510(k) review time under this name: 45 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | 7 | 7 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 6 | 6 |
| JJO | Flame Emission Photometer For Clinical Use | 6 | 6 |
| JGS | Electrode, Ion Specific, Sodium | 4 | 4 |
| JIS | Calibrator, Primary | 2 | 2 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 2 | 2 |
| KPA | Slide Stainer, Automated | 2 | 2 |
| JFL | Ph Rate Measurement, Carbon-Dioxide | 1 | 1 |
| JGT | Flame Photometry, Sodium | 1 | 1 |
| JIH | Flame Photometry, Lithium | 1 | 1 |
Plus 3 more product codes.
Review panels
- Clinical Chemistry (30)
- Clinical Toxicology (3)
- Pathology (2)
Most recent Shaban Mfg. Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853621 | REPLACEMENT PUMP TUBING | JJE | 1985-12-05 | 98 |
| K850333 | PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS | KPA | 1985-02-27 | 30 |
| K850157 | CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS | KPA | 1985-02-27 | 43 |
| K844781 | MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB | CHL | 1985-02-01 | 53 |
| K844235 | CHLORIDE STANDARD | JIS | 1984-11-20 | 19 |
| K842656 | REPLACEMENT PARTS NOVA ELECTROLYTE ANAL | JFL | 1984-08-12 | 33 |
| K841610 | COMPONENTS FOR POTASSIUM, SODIUM CHLO | JGT | 1984-05-25 | 46 |
| K841609 | COMPONENTS FOR PARTIAL PRESSURE ELEE | CHL | 1984-05-25 | 46 |
| K840557 | REAGENTS & STANDARDS IL 501 NA/K | JGS | 1984-04-04 | 56 |
| K840530 | SUPPLIES FOR INSTRUMENTATION LAB FLAME | JJO | 1984-03-30 | 65 |
25 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shaban Mfg. Co..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Shaban Mfg. Co.?
FDA lists 35 510(k) clearances under the applicant name “Shaban Mfg. Co.” (first 1982, latest 1985), across 13 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 Shaban Mfg. Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shaban Mfg. Co. is 45 days.
Which FDA product codes appear under Shaban Mfg. Co.?
The most frequent FDA product codes under this applicant name are JIX (Calibrator, Multi-Analyte Mixture, 7); CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 6); JJO (Flame Emission Photometer For Clinical Use, 6).
Next steps
- See all 35 Shaban Mfg. Co. clearances with predicates and recalls
- Run predicate analysis for product code JIX, Shaban Mfg. Co.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.