Sigma Ammonia Reagent
FDA 510(k) K760332 · Sigma Chemical Co.
510(k) numberK760332
Submission
- Device name
- Sigma Ammonia Reagent
- Applicant
- Sigma Chemical Co.
Mchenry, IL, US - Received
- July 28, 1976
- Decision date
- August 23, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIF – Enzymatic Method, Ammonia
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1065
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JIF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183517 | Ammonia IIJIF · Traditional | Roche Diagnostics Operations (Rdo) | 02/08/2019SE |
| K123677 | Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator (Chem 3 Cal)JIF · Traditional | Siemens Healthcare Diagnostics | 03/07/2013SE |
| K123320 | Dimension Ammonia Flex Reagent CartridgeJIF · Traditional | Siemens Healthcare Diagnostics | 02/15/2013SE |
| K062316 | Dimension Vista Ammonia (Amon) Flex Reagent CartridgeJIF · Special | Dade Behring, Inc. | 09/06/2006SE |
| K051114 | Sentinel Ammonia Ultra Diagnostic AssayJIF · Traditional | Sentinel Ch. Srl | 11/25/2005SE |
| K033921 | AMMONIA-L3K Assay, Catalogue Number 233-10JIF · Traditional | Diagnostic Chemicals , Ltd. | 03/10/2004SE |
| K030873 | Randox AmmoniaJIF · Traditional | Randox Laboratories, Ltd. | 05/12/2003SE |
| K023841 | Ammonia Assay for the Advia 1650JIF · Traditional | Bayer Diagnostics Corp. | 12/24/2002SE |
| K021151 | Ammonia Assay for the Advia Integrated Modular SystemJIF · Traditional | Bayer Diagnostics Corp. | 07/13/2002SE |
| K003196 | Synchron Systems Ammonia ReagentJIF · Traditional | Beckman Coulter, Inc. | 12/22/2000SE |
More from Beckman Coulter, 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 |
| K933679 | Sigma Bun ReagentLFP · 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 |
Questions and answers
When was Sigma Ammonia Reagent cleared by the FDA?
Sigma Ammonia Reagent (K760332) received a 510(k) decision of Substantially Equivalent on August 23, 1976, 26 days after the submission was received.
What is the product code of K760332?
The FDA product code is JIF – Enzymatic Method, Ammonia, a Class I (low risk) device regulated under 21 CFR 862.1065.