Sodium/Potassium Buffer Solution
FDA 510(k) K791692 · Hi Chem, Inc.
510(k) numberK791692
Submission
- Device name
- Sodium/Potassium Buffer Solution
- Applicant
- Hi Chem, Inc.
Mchenry, IL, US - Received
- July 31, 1979
- Decision date
- September 17, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEM – Electrode, Ion Specific, Potassium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1600
- Specialty
- Clinical Chemistry
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|---|---|---|
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| 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 Sodium/Potassium Buffer Solution cleared by the FDA?
Sodium/Potassium Buffer Solution (K791692) received a 510(k) decision of Substantially Equivalent on September 17, 1979, 48 days after the submission was received.
What is the product code of K791692?
The FDA product code is CEM – Electrode, Ion Specific, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.