Hichem Ion 2/4 Urine Range Calibrator
FDA 510(k) K842450 · Hi Chem, Inc.
510(k) numberK842450
Submission
- Device name
- Hichem Ion 2/4 Urine Range Calibrator
- Applicant
- Hi Chem, Inc.
Mchenry, IL, US - Received
- June 22, 1984
- Decision date
- August 16, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIS – Calibrator, Primary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K030964 | Calibration Plasma LMW HeparinJIS · Traditional | Instrumentation Laboratory CO | 06/06/2003SE |
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| 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 |
Questions and answers
When was Hichem Ion 2/4 Urine Range Calibrator cleared by the FDA?
Hichem Ion 2/4 Urine Range Calibrator (K842450) received a 510(k) decision of Substantially Equivalent on August 16, 1984, 55 days after the submission was received.
What is the product code of K842450?
The FDA product code is JIS – Calibrator, Primary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.