Bun Reagent Kit
FDA 510(k) K873132 · A-Kem, Inc.
510(k) numberK873132
Submission
- Device name
- Bun Reagent Kit
- Applicant
- A-Kem, Inc.
Clifton, NJ, US - Received
- August 10, 1987
- Decision date
- October 23, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K992847 | Hichem Bun ReagentLFP · Traditional | Elan Holdings, Inc. | 10/14/1999SE |
| K963537 | Sigma Diagnostics Bun ReagentLFP · Traditional | Sigma Diagnostics, Inc. | 10/24/1996SE |
| K933679 | Sigma Bun ReagentLFP · Traditional | Sigma Chemical Co. | 12/17/1993SE |
| K812945 | Liquilyme Bun ReagentLFP · Traditional | Amresco, Inc. | 11/06/1981SE |
More from Amresco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K884224 | Total Bilirubin Reagent Kit for Astra SystemsCIG · Traditional | 12/15/1988SE |
| K884227 | Calibrator Standard Kit for Astra SystemJIX · Traditional | 12/09/1988SE |
| K884226 | Amylase Reagent Kit for Astra SystemsCJA · Traditional | 12/09/1988SE |
| K884225 | Total Protein Reagent Kit for Astra SystemsCEK · Traditional | 12/09/1988SE |
| K882587 | A-Kem Albumin Reagent Kit for Astra SystemCIX · Traditional | 08/08/1988SE |
| K882586 | A-Kem Calcium Reagent Kit for Astra SystemCIC · Traditional | 08/08/1988SE |
| K873131 | Creatinine Reagent KitCGX · Traditional | 10/23/1987SE |
| K873130 | Wash Solution KitJJE · Traditional | 10/23/1987SE |
| K873129 | Carbon Dioxide Reagent KitJFL · Traditional | 10/23/1987SE |
| K873128 | Glucose Reagent KitCGA · Traditional | 10/23/1987SE |
Questions and answers
When was Bun Reagent Kit cleared by the FDA?
Bun Reagent Kit (K873132) received a 510(k) decision of Substantially Equivalent on October 23, 1987, 74 days after the submission was received.
What is the product code of K873132?
The FDA product code is LFP – Conductivity Rate, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.