Elitechgroup: FDA clearances and approvals
Elitechgroup has 18 FDA 510(k) clearances (first 2011, latest 2018), across 14 product codes in 3 review panels. Median 510(k) review time: 75 days. Since 2017 its median was 140 days, against 131 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 26 |
| 2013 | 2 | 111 |
| 2014 | 2 | 110 |
| 2015 | 2 | 58 |
| 2016 | 1 | 261 |
| 2017 | 1 | 60 |
| 2018 | 2 | 191 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Elitechgroup's cleared 510(k)s took a median 140 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | 3 | 3 |
| CIG | Diazo Colorimetry, Bilirubin | 2 | 2 |
| JHW | U.V. Method, Cpk Isoenzymes | 2 | 2 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| CJY | Azo Dye, Calcium | 1 | 1 |
| JFJ | Catalytic Methods, Amylase | 1 | 1 |
| JFY | Enzymatic Method, Creatinine | 1 | 1 |
| JIT | Calibrator, Secondary | 1 | 1 |
Plus 4 more product codes.
Review panels
- Clinical Chemistry (16)
- Microbiology (1)
- Physical Medicine (1)
Most recent Elitechgroup 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180559 | HSV 1 & 2 ELITe MGB Kit; ELITe InGenius | PGI | 2018-10-29 | 242 |
| K180627 | Macroduct Advanced Model 3710 | KTB | 2018-07-27 | 140 |
| K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 | CIG | 2017-07-11 | 60 |
| K153644 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II | CFR | 2016-09-07 | 261 |
| K151113 | ELITech Clinical Systems CALCIUM ARSENAZO | CJY | 2015-07-22 | 86 |
| K151552 | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II | JIX | 2015-07-08 | 29 |
| K141265 | ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT | JHW | 2014-07-18 | 64 |
| K132399 | ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL | JFY | 2014-01-03 | 155 |
| K130765 | ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II | JIX | 2013-04-04 | 15 |
| K122177 | ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL | JIT | 2013-02-15 | 207 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Elitechgroup.
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 Elitechgroup have?
Elitechgroup has 18 FDA 510(k) clearances (first 2011, latest 2018), across 14 product codes in 3 review panels.
How long does FDA take to clear Elitechgroup's 510(k)s?
The median time from FDA receipt to decision across Elitechgroup's cleared 510(k)s is 75 days. Since 2017: 140 days, versus 131 days for all cleared 510(k)s in the same product codes.
What devices does Elitechgroup make?
Its most frequent FDA product codes are JIX (Calibrator, Multi-Analyte Mixture, 3); CIG (Diazo Colorimetry, Bilirubin, 2); JHW (U.V. Method, Cpk Isoenzymes, 2).
Has Elitechgroup had device recalls?
openFDA lists no recalls under a recalling firm name matching Elitechgroup. Related entities may recall under other names.
Next steps
- See all 18 Elitechgroup clearances with predicates and recalls
- Run predicate analysis for product code JIX, Elitechgroup'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.