Hichem Diagnostics: FDA filings under this applicant name
FDA lists 41 510(k) clearances under the applicant name “Hichem Diagnostics” (first 1988, latest 1998), across 24 product codes in 1 review panel. Median 510(k) review time under this name: 50 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 7 | 7 |
| JIX | Calibrator, Multi-Analyte Mixture | 4 | 4 |
| CGZ | Electrode, Ion-Specific, Chloride | 3 | 3 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 | 2 |
| CJY | Azo Dye, Calcium | 2 | 2 |
| JFL | Ph Rate Measurement, Carbon-Dioxide | 2 | 2 |
| JGS | Electrode, Ion Specific, Sodium | 2 | 2 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 2 | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 | 2 |
| CDS | Electrode, Ion Specific, Urea Nitrogen | 1 | 1 |
Plus 14 more product codes.
Review panels
- Clinical Chemistry (41)
Most recent Hichem Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981794 | HICHEM CALCIUM REAGENT KIT | CJY | 1998-07-29 | 69 |
| K963383 | HICHEM ALP/AMP REAGENT KIT | CKF | 1996-09-23 | 27 |
| K953863 | HICHEM ISE STANDARDS KIT 70011 | JIX | 1995-09-06 | 20 |
| K953862 | HICHEM ISEKCI SOLUTION KIT 70010 | CGZ | 1995-09-06 | 20 |
| K953861 | HICHEM ISE INTDERNAL REFERENCE KIT 70009 | CGZ | 1995-09-06 | 20 |
| K953860 | HICHEM ISE DILUENT KIT 70008 | CGZ | 1995-09-06 | 20 |
| K951751 | HICHEM AST REAGENT KIT | CIT | 1995-08-02 | 107 |
| K946192 | HICHEM Y-GT REAGENT KIT | JQB | 1995-05-02 | 133 |
| K946022 | HICHEM LDH/L REAGENT KIT | CFJ | 1995-02-23 | 73 |
| K941433 | HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH | JJX | 1994-08-02 | 131 |
31 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hichem Diagnostics.
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 Hichem Diagnostics?
FDA lists 41 510(k) clearances under the applicant name “Hichem Diagnostics” (first 1988, latest 1998), across 24 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hichem Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hichem Diagnostics is 50 days.
Which FDA product codes appear under Hichem Diagnostics?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 7); JIX (Calibrator, Multi-Analyte Mixture, 4); CGZ (Electrode, Ion-Specific, Chloride, 3).
Next steps
- See all 41 Hichem Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code JJY, Hichem Diagnostics'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.