Ammonia/Iron Standard Kit
FDA 510(k) K972333 · Verichem Laboratories, Inc.
510(k) numberK972333
Submission
- Device name
- Ammonia/Iron Standard Kit
- Applicant
- Verichem Laboratories, Inc.
Providence, RI, US - Received
- June 23, 1997
- Decision date
- July 23, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K123321 | Dimension Chemistry III CalibratoryJIX · Traditional | Siemens Healthcare Diagnostics | 02/15/2013SE |
| K123372 | Abbott Lipid Multi Constituent CalibratorJIX · Traditional | Abbott Laboratories | 01/14/2013SE |
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More from Siemens Healthcare Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K112834 | Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Stardand Kit…JIX · Abbreviated | 03/28/2012SE |
| K974290 | Microprotein Standard KitJIX · Traditional | 12/19/1997SE |
| K973345 | Matrix Plus Multi-Calibrator KitJIX · Traditional | 10/29/1997SE |
| K924904 | Hdl-Cholesterol Standard, ModificationJIS · Traditional | 01/13/1993SE |
| K912513 | Electrolyte ControlJJR · Traditional | 07/19/1991SE |
| K901113 | Matrix Plus(Tm) Chemistry Reference StandardJIS · Traditional | 03/29/1990SE |
| K882059 | Bilirubin StandardJIT · Traditional | 10/25/1988SE |
| K881320 | Urine Toxicology StandardDKB · Traditional | 09/09/1988SE |
| K875285 | Multi-Chemistry Linearity StandardJIX · Traditional | 09/02/1988SE |
| K882117 | Ethyl Alcohol StandardDNN · Traditional | 08/04/1988SE |
Questions and answers
When was Ammonia/Iron Standard Kit cleared by the FDA?
Ammonia/Iron Standard Kit (K972333) received a 510(k) decision of Substantially Equivalent on July 23, 1997, 30 days after the submission was received.
What is the product code of K972333?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.