Hi Chem, Inc.
Medical device manufacturer in Brea, CA.
52510(k) clearances
0PMA approvals
0recalls
Device types
- CGX Alkaline Picrate, Colorimetry, Creatinine 3
- JGS Electrode, Ion Specific, Sodium 3
- CEM Electrode, Ion Specific, Potassium 3
- JIX Calibrator, Multi-Analyte Mixture 3
- JJY Multi-Analyte Controls, All Kinds (Assayed) 3
- CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 3
- CGA Glucose Oxidase, Glucose 3
- JIS Calibrator, Primary 3
- JJE Analyzer, Chemistry (Photometric… 2
- JFS Coulometric, Chloride 2
- JFL Ph Rate Measurement, Carbon-Dioxide 2
- CIG Diazo Colorimetry, Bilirubin 2
- JJF Analyzer, Chemistry, Micro, For Clinical Use 2
- CFJ Nad Reduction/Nadh Oxidation, Lactate… 2
- CDS Electrode, Ion Specific, Urea Nitrogen 1
- CIC Cresolphthalein Complexone, Calcium 1
- CFR Hexokinase, Glucose 1
- KNK Acid, Uric, Uricase (Colorimetric) 1
- JGT Flame Photometry, Sodium 1
- LCP Assay, Glycosylated Hemoglobin 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K960084 | Hichem Glucose/Hk Reagent KitCFR · Traditional | 04/04/1996SE |
| K951818 | Hichem Alt Reagent KitCKA · Traditional | 05/15/1995SE |
| K943684 | Hichem Enzyme Verifier KitJJT · Traditional | 10/04/1994SE |
| K941764 | Hichem Calcium Reagent for the Synchron CX3 Prod. No. 88808CJY · Traditional | 05/13/1994SE |
| K902673 | Hi Chem Total Protein/Albumin Serum Range Lin STNDJJY · Traditional | 07/17/1990SE |
| K863617 | Ion 2/4 Flow Cell Cleaner (Product #88656)JGS · Traditional | 10/24/1986SE |
| K862027 | LDP Reagent Cartridge (No. 88216)CFJ · Traditional | 06/13/1986SE |
| K861893 | GGT Reagent Cartridge (Product No. 88204)JXL · Traditional | 06/05/1986SE |
| K861879 | CK Reagent Cartridge (Product No. 88213)CGS · Traditional | 05/29/1986SE |
| K861419 | Hi Chem Diagnostics LDL Reagent CartridgeCFJ · Traditional | 04/28/1986SE |
| K861284 | Ap Reagent CartridgeCJE · Traditional | 04/28/1986SE |
| K861283 | Ast Reagent CartridgeCIT · Traditional | 04/28/1986SE |
| K861231 | Alt Reagent Cartridge (Product No. 88210)CKA · Traditional | 04/28/1986SE |
| K855196 | Cleaning Reagent Kit Product No 88194JJE · Traditional | 01/22/1986SE |
| K852867 | Hi-Chem Diagnostics Enzyme Rinse ConcentrateCKA · Traditional | 08/29/1985SE |
| K853003 | Hi Chem Diagnostics Cleaning Neutralizer SOL#88193JJE · Traditional | 08/06/1985SE |
| K851350 | Ion 2 Reagent KiCEM · Traditional | 04/29/1985SE |
| K850405 | Calibrator B 88133JIX · Traditional | 04/01/1985SE |
| K842450 | Hichem Ion 2/4 Urine Range CalibratorJIS · Traditional | 08/16/1984SE |
| K842449 | Hichem Ion 2/4 Serum Range CalibratorJIS · Traditional | 08/16/1984SE |
| K842025 | Ion 4 Sodium/Potassium/Chloride/TotalJGS · Traditional | 06/22/1984SE |
| K841572 | Direct Bilirubin ReagentCIG · Traditional | 05/16/1984SE |
| K833159 | Potassium Electrode Tip Assambly-K-CEM · Traditional | 11/25/1983SE |
| K831295 | Amylase Reagent #88129KHM · Traditional | 06/30/1983SE |
| K830714 | Total Bilirubin ReagentCIG · Traditional | 04/06/1983SE |
| K830137 | Calibrator aJIS · Traditional | 02/07/1983SE |
| K821225 | Albumin ReagentCIX · Traditional | 05/21/1982SE |
| K820090 | Astra-T Calcium ReagentCIC · Traditional | 01/28/1982SE |
| K813536 | Astra Total Protein ReagentCEK · Traditional | 12/31/1981SE |
| K813370 | Electrolyte GelCGA · Traditional | 12/22/1981SE |
| K812700 | UricarKNK · Traditional | 11/05/1981SE |
| K802264 | Wash Solution Kit, #88102JJF · Traditional | 10/31/1980SE |
| K802392 | Astra Printer Paper #88112-CHLORIDE SilvJJF · Traditional | 10/23/1980SE |
| K801892 | Klinar Reagent Pak, #36010JGT · Traditional | 10/23/1980SE |
| K800616 | Bun Reagent Kit #88108CDS · Traditional | 04/10/1980SE |
| K791365 | Fast Flow #60310LCP · Traditional | 09/27/1979SE |
| K791696 | Contro IIJJY · Traditional | 09/24/1979SE |
| K791695 | Contro IJJY · Traditional | 09/24/1979SE |
| K791694 | Calibrator IIJIX · Traditional | 09/17/1979SE |
| K791693 | Calibrator IJIX · Traditional | 09/17/1979SE |
| K791692 | Sodium/Potassium Buffer SolutionCEM · Traditional | 09/17/1979SE |
| K791691 | Sodium/Potassium Conditioning SolutionJGS · Traditional | 09/17/1979SE |
| K791690 | Cholorde ReagentJFS · Traditional | 09/17/1979SE |
| K791689 | Picric SolutionCGX · Traditional | 09/17/1979SE |
| K791688 | Alkaline BufferCGX · Traditional | 09/17/1979SE |
| K791687 | CO2 Reference ReagentJFL · Traditional | 09/17/1979SE |
| K791686 | CO2 Cup ReagentJFL · Traditional | 09/17/1979SE |
| K791685 | Glucose ReagentCGA · Traditional | 09/17/1979SE |
| K782094 | HilarCGX · Traditional | 01/17/1979SE |
| K781132 | ChemlarJFS · Traditional | 08/10/1978SE |
| K771731 | Cholar Produ&T #17010CHH · Traditional | 10/25/1977SE |
| K771000 | TrendarCGA · Traditional | 07/15/1977SE |