Hichem Bun Reagent
FDA 510(k) K992847 · Elan Holdings, Inc.
510(k) numberK992847
Submission
- Device name
- Hichem Bun Reagent
- Applicant
- Elan Holdings, Inc.
Brea, CA, US - Received
- August 24, 1999
- Decision date
- October 14, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFP – Conductivity Rate, Urea Nitrogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1770
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LFP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K990039 | Gambro DQM 200LFP · Traditional | Gambro Healthcare | 01/27/2000SE |
| K963537 | Sigma Diagnostics Bun ReagentLFP · Traditional | Sigma Diagnostics, Inc. | 10/24/1996SE |
| K933679 | Sigma Bun ReagentLFP · Traditional | Sigma Chemical Co. | 12/17/1993SE |
| K873132 | Bun Reagent KitLFP · Traditional | A-Kem, Inc. | 10/23/1987SE |
| K812945 | Liquilyme Bun ReagentLFP · Traditional | Amresco, Inc. | 11/06/1981SE |
More from Amresco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K010488 | Atac Pak Ast Reagent KitCIT · Traditional | 04/09/2001SE |
| K000958 | Atac Pak Bun Reagent and Atac Calibrator KitsCDQ · Traditional | 05/24/2000SE |
| K000900 | Atac Pak Cholesterol Reagent and Atac Callibrator KitsCHH · Traditional | 05/02/2000SE |
| K992844 | Hichem Ise Electrolyte BufferJGS · Traditional | 11/26/1999SE |
| 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 |
| K991789 | Atac-Pak Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator KitsLBR · Traditional | 07/09/1999SE |
Questions and answers
When was Hichem Bun Reagent cleared by the FDA?
Hichem Bun Reagent (K992847) received a 510(k) decision of Substantially Equivalent on October 14, 1999, 51 days after the submission was received.
What is the product code of K992847?
The FDA product code is LFP – Conductivity Rate, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.