Sigma Bun Reagent
FDA 510(k) K933679 · Sigma Chemical Co.
510(k) numberK933679
Submission
- Device name
- Sigma Bun Reagent
- Applicant
- Sigma Chemical Co.
St. Louis, MO, US - Received
- July 28, 1993
- Decision date
- December 17, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K992847 | Hichem Bun ReagentLFP · Traditional | Elan Holdings, Inc. | 10/14/1999SE |
| K963537 | Sigma Diagnostics Bun ReagentLFP · Traditional | Sigma Diagnostics, Inc. | 10/24/1996SE |
| 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 |
|---|---|---|
| K933694 | Sigma Glucose ReagentCGA · Traditional | 11/04/1994SE |
| K933678 | Sigma Calcium ReagentCJY · Traditional | 03/11/1994SE |
| K933696 | Sigma Electrolyte Reference ReagentJFL · Traditional | 01/03/1994SE |
| K933691 | Sigma CO2 Alkaline Buffer ReagentJFL · Traditional | 12/17/1993SE |
| K933703 | Sigma Wash Concentrate SolutionJJE · Traditional | 12/10/1993SE |
| K933692 | Sigma CO2 Acid ReagentJFL · Traditional | 12/09/1993SE |
| K933695 | Sigma Electrolyte BufferJFL · Traditional | 10/22/1993SE |
| K933697 | Sigma Cre ReagentCGX · Traditional | 10/18/1993SE |
| K933693 | Sigma CX-3 Calibration Standard Level 2JIX · Traditional | 10/13/1993SE |
| K933702 | Sigma CX-3 Calibration Standard Level 1JIX · Traditional | 10/08/1993SE |
Questions and answers
When was Sigma Bun Reagent cleared by the FDA?
Sigma Bun Reagent (K933679) received a 510(k) decision of Substantially Equivalent on December 17, 1993, 142 days after the submission was received.
What is the product code of K933679?
The FDA product code is LFP – Conductivity Rate, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.