Hichem Ise Electrolyte Buffer
FDA 510(k) K992844 · Elan Holdings, Inc.
510(k) numberK992844
Submission
- Device name
- Hichem Ise Electrolyte Buffer
- Applicant
- Elan Holdings, Inc.
Brea, CA, US - Received
- August 24, 1999
- Decision date
- November 26, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Specialty
- Clinical Chemistry
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| K013152 | Atac Pak Direct HDL Reagent and Atac Direct HDL Calibrator KitsLBS · Traditional | 11/09/2001SE |
| K012474 | Atac Pak CPK Reagent KitCGS · Traditional | 10/03/2001SE |
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| K000900 | Atac Pak Cholesterol Reagent and Atac Callibrator KitsCHH · Traditional | 05/02/2000SE |
| K992842 | Hichem Ise Electrolyte ReferenceJGS · Traditional | 11/26/1999SE |
| K992846 | Hichem Total Protein ReagentCEK · Traditional | 10/18/1999SE |
| K992845 | Hichem Calibrator 1 Kit, Hichem Calibrator 2 Kit, Hichem Calibrator 3 Kit, Calibration…JIX · Traditional | 10/18/1999SE |
| K992847 | Hichem Bun ReagentLFP · Traditional | 10/14/1999SE |
| K991789 | Atac-Pak Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator KitsLBR · Traditional | 07/09/1999SE |
Questions and answers
When was Hichem Ise Electrolyte Buffer cleared by the FDA?
Hichem Ise Electrolyte Buffer (K992844) received a 510(k) decision of Substantially Equivalent on November 26, 1999, 94 days after the submission was received.
What is the product code of K992844?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.