Hi Chem, Inc.: FDA filings under this applicant name
FDA lists 52 510(k) clearances under the applicant name “Hi Chem, Inc.” (first 1977, latest 1996), across 30 product codes in 3 review panels. Median 510(k) review time under this name: 42 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 |
|---|---|---|---|
| CEM | Electrode, Ion Specific, Potassium | 3 | 3 |
| CGA | Glucose Oxidase, Glucose | 3 | 3 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 3 | 3 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 3 | 3 |
| JGS | Electrode, Ion Specific, Sodium | 3 | 3 |
| JIS | Calibrator, Primary | 3 | 3 |
| JIX | Calibrator, Multi-Analyte Mixture | 3 | 3 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 3 | 3 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 | 2 |
| CIG | Diazo Colorimetry, Bilirubin | 2 | 2 |
Plus 20 more product codes.
Review panels
- Clinical Chemistry (50)
- Hematology (1)
- Neurology (1)
Most recent Hi Chem, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960084 | HICHEM GLUCOSE/HK REAGENT KIT | CFR | 1996-04-04 | 84 |
| K951818 | HICHEM ALT REAGENT KIT | CKA | 1995-05-15 | 25 |
| K943684 | HICHEM ENZYME VERIFIER KIT | JJT | 1994-10-04 | 67 |
| K941764 | HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 | CJY | 1994-05-13 | 45 |
| K902673 | HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND | JJY | 1990-07-17 | 29 |
| K863617 | ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) | JGS | 1986-10-24 | 38 |
| K862027 | LDP REAGENT CARTRIDGE (NO. 88216) | CFJ | 1986-06-13 | 16 |
| K861893 | GGT REAGENT CARTRIDGE (PRODUCT NO. 88204) | JXL | 1986-06-05 | 20 |
| K861879 | CK REAGENT CARTRIDGE (PRODUCT NO. 88213) | CGS | 1986-05-29 | 14 |
| K861419 | HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE | CFJ | 1986-04-28 | 13 |
42 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hi Chem, Inc..
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 Hi Chem, Inc.?
FDA lists 52 510(k) clearances under the applicant name “Hi Chem, Inc.” (first 1977, latest 1996), across 30 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 Hi Chem, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hi Chem, Inc. is 42 days.
Which FDA product codes appear under Hi Chem, Inc.?
The most frequent FDA product codes under this applicant name are CEM (Electrode, Ion Specific, Potassium, 3); CGA (Glucose Oxidase, Glucose, 3); CGX (Alkaline Picrate, Colorimetry, Creatinine, 3).
Next steps
- See all 52 Hi Chem, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CEM, Hi Chem, Inc.'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.