Ammonia Reagent Set
FDA 510(k) K915707 · Tech Intl. Co.
510(k) numberK915707
Submission
- Device name
- Ammonia Reagent Set
- Applicant
- Tech Intl. Co.
Rochester Hills, MI, US - Received
- November 29, 1991
- Decision date
- February 26, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K915704 | Amylase (Kinetic) Reagent SetCJD · Traditional | 06/28/1996SE |
| K915705 | Acid Phosphatase Reagent SetCKE · Traditional | 02/27/1992SE |
| K914158 | Uric Acid Reagent SetKNK · Traditional | 02/21/1992SE |
| K915706 | Lipase Reagent SetCET · Traditional | 02/18/1992SE |
| K915710 | Amylase (Colorimetric) Reagent SetJFJ · Traditional | 01/30/1992SE |
| K914160 | Cholesterol Regeant SetCHH · Traditional | 01/30/1992SE |
| K915709 | Creatine Kinase-Mb (Ck-Mb) Reagent SetCGS · Traditional | 01/27/1992SE |
| K914159 | Glucose Reagent SetCGA · Traditional | 01/27/1992SE |
| K915708 | Inorganic Phosphorus(Colorimetric) Reagent SetCEO · Traditional | 01/22/1992SE |
| K914171 | In Vitro Diagnostic Regeant Set,CholinesteraseDIH · Traditional | 12/18/1991SE |
Questions and answers
When was Ammonia Reagent Set cleared by the FDA?
Ammonia Reagent Set (K915707) received a 510(k) decision of Substantially Equivalent on February 26, 1992, 89 days after the submission was received.
What is the product code of K915707?
The FDA product code is JIF – Enzymatic Method, Ammonia, a Class I (low risk) device regulated under 21 CFR 862.1065.