Hichem Diagnostics
Medical device manufacturer in Brea, CA.
41510(k) clearances
0PMA approvals
0recalls
Device types
- JJY Multi-Analyte Controls, All Kinds (Assayed) 7
- JIX Calibrator, Multi-Analyte Mixture 4
- CGZ Electrode, Ion-Specific, Chloride 3
- CHH Enzymatic Esterase--Oxidase, Cholesterol 2
- JJE Analyzer, Chemistry (Photometric… 2
- CJY Azo Dye, Calcium 2
- JGS Electrode, Ion Specific, Sodium 2
- JFL Ph Rate Measurement, Carbon-Dioxide 2
- JJX Single (Specified) Analyte Controls… 2
- JIS Calibrator, Primary 1
- CKF Phenylphosphate, Alkaline Phosphatase Or… 1
- CGA Glucose Oxidase, Glucose 1
- CDS Electrode, Ion Specific, Urea Nitrogen 1
- JJT Enzyme Controls (Assayed And Unassayed) 1
- JIM Method, Metallic Reduction, Glucose… 1
- CJA Amyloclastic, Amylase 1
- CGX Alkaline Picrate, Colorimetry, Creatinine 1
- CEO Phosphomolybdate (Colorimetric), Inorganic… 1
- JQW Station, Pipetting And Diluting, For… 1
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K981794 | Hichem Calcium Reagent KitCJY · Traditional | 07/29/1998SE |
| K963383 | Hichem Alp/Amp Reagent KitCKF · Traditional | 09/23/1996SE |
| K953863 | Hichem Ise Standards Kit 70011JIX · Traditional | 09/06/1995SE |
| K953862 | Hichem Isekci Solution Kit 70010CGZ · Traditional | 09/06/1995SE |
| K953861 | Hichem Ise Intdernal Reference Kit 70009CGZ · Traditional | 09/06/1995SE |
| K953860 | Hichem Ise Diluent Kit 70008CGZ · Traditional | 09/06/1995SE |
| K951751 | Hichem Ast Reagent KitCIT · Traditional | 08/02/1995SE |
| K946192 | Hichem Y-Gt Reagent KitJQB · Traditional | 05/02/1995SE |
| K946022 | Hichem Ldh/L Reagent KitCFJ · Traditional | 02/23/1995SE |
| K941433 | Hi Chem Aqueous Glucose Control, Low, Med, HighJJX · Traditional | 08/02/1994SE |
| K925612 | Hi Chem Electrolyte BufferJGS · Traditional | 04/20/1993SE |
| K925551 | Hi Chem Glucose Reagent Kit, Product No. 88807CGA · Traditional | 04/20/1993SE |
| K925550 | Hi Chem Bun Reagent Kit,Product Number 88806CDS · Traditional | 04/20/1993SE |
| K925611 | Hi Chem Electrolyte Reference ReagentJGS · Traditional | 02/23/1993SE |
| K925553 | Hi Chem CO2 Alkaline Buffer Reagent KIT,PROD#88813JFL · Traditional | 02/12/1993SE |
| K925552 | Hi Chem CO2 Acid Reagent Kit,Product Number 88812JFL · Traditional | 02/12/1993SE |
| K913792 | Hi Chem Low/Mid/High Aqueous Glucose ControlJJX · Traditional | 09/25/1991SE |
| K911803 | Hi Chem Aqueous Multianalyte Line Stand, ModifiedJJY · Traditional | 05/15/1991SE |
| K904099 | Uric Acid/Iron/Magnesium Linearity StandardsJJY · Traditional | 10/26/1990SE |
| K904293 | Hi Chem Bilirubin Linearity Set (Product #88237)JJY · Traditional | 10/12/1990SE |
| K903888 | Hi Chem Protein/Lipids LinearityJIX · Traditional | 09/27/1990SE |
| K902321 | Hi Chem Enzyme Linearity Standards (Prod. 88235)JJT · Traditional | 06/28/1990SE |
| K902155 | Hi Chem Ise Reagents (Products #88960 and #88964)JIM · Traditional | 06/12/1990SE |
| K901115 | Multiconstituent Serum Range Linearity #88234JJY · Traditional | 04/19/1990SE |
| K895555 | Modified Hi Chem Amylase Reagent (Product #88129)CJA · Traditional | 12/22/1989SE |
| K895585 | Hi Chem Triglycerides Calibrator E (88185)JIS · Traditional | 11/13/1989SE |
| K895135 | Hi Chem Calibrator A+JIX · Traditional | 10/23/1989SE |
| K890671 | Hi Chem Creatinine Reagent (Product #88809)CGX · Traditional | 05/09/1989SE |
| K890773 | Hi Chem Inorganic Phosphorus Reagent Kit #88196CEO · Traditional | 04/18/1989SE |
| K890990 | Extend Intended Use for Enzyme Rinse ConcentrateCHH · Traditional | 04/10/1989SE |
| K890584 | Hi Chem Calcium Reagent #88808CJY · Traditional | 04/10/1989SE |
| K890583 | Hi Chem Calibration Standards Levels 1 and 2JIX · Traditional | 03/13/1989SE |
| K890578 | Hi Chem Wash Concentrate Reagent #88805JQW · Traditional | 03/10/1989SE |
| K890184 | Modified Intended Use of Cleaning Reagent KitJJE · Traditional | 02/07/1989SE |
| K890183 | Modified Intended Use on Cleaning Neutralizer Sol.JJE · Traditional | 02/07/1989SE |
| K883844 | Hi Chem Kinetic Cholesterol Reagent #88218CHH · Traditional | 10/31/1988SE |
| K883405 | Triglycerides Reagent (Product #88218)CDT · Traditional | 09/13/1988SE |
| K883404 | Uric Acid Reagent (Product #88219)KNK · Traditional | 09/13/1988SE |
| K881438 | Urea/Glucose/Creatinine Serum Range Linearity StanJJY · Traditional | 07/06/1988SE |
| K881437 | Chloride/Total CO2 Serum Range Linearity StandardsJJY · Traditional | 07/06/1988SE |
| K881436 | Sodium/Potassium Serum Range Linearity StandardsJJY · Traditional | 06/02/1988SE |