Hichem Isekci Solution Kit 70010
FDA 510(k) K953862 · Hichem Diagnostics
510(k) numberK953862
Submission
- Device name
- Hichem Isekci Solution Kit 70010
- Applicant
- Hichem Diagnostics
Brea, CA, US - Received
- August 17, 1995
- Decision date
- September 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGZ – Electrode, Ion-Specific, Chloride
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1170
- Specialty
- Clinical Chemistry
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| 510(k) | Device | Decision |
|---|---|---|
| K981794 | Hichem Calcium Reagent KitCJY · Traditional | 07/29/1998SE |
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| K953863 | Hichem Ise Standards Kit 70011JIX · 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 |
Questions and answers
When was Hichem Isekci Solution Kit 70010 cleared by the FDA?
Hichem Isekci Solution Kit 70010 (K953862) received a 510(k) decision of Substantially Equivalent on September 6, 1995, 20 days after the submission was received.
What is the product code of K953862?
The FDA product code is CGZ – Electrode, Ion-Specific, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.