Data-Zyme Urea Nitrogen Reagent Set
FDA 510(k) K802061 · Data Medical Associates, Inc.
510(k) numberK802061
Submission
- Device name
- Data-Zyme Urea Nitrogen Reagent Set
- Applicant
- Data Medical Associates, Inc.
Mchenry, IL, US - Received
- August 25, 1980
- Decision date
- September 26, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1770
- Specialty
- Clinical Chemistry
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|---|---|---|---|
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| K024182 | Precision Systems Analette Chemistry Analyzer Stanbio Laboratory ReagentsCDQ · Traditional | Precision Systems, Inc. | 03/03/2003SE |
| K021385 | Atac Pak Bun ReagentCDQ · Traditional | Elan Diagnostics | 07/12/2002SE |
| K012649 | Raichem Bun Rate ReagentCDQ · Traditional | Hemagen Diagnostics, Inc. | 10/15/2001SE |
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| 510(k) | Device | Decision |
|---|---|---|
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| K971113 | Dma Triglycerides ProceduresCDT · Traditional | 05/29/1997SE |
| K961919 | Dma Gamma Glutamyltransferase (GGT) ProcedureJPZ · Traditional | 07/01/1996SE |
| K955796 | Iron Calibrator & Calibration Verification SetJJX · Traditional | 02/29/1996SE |
| K955302 | Serum Bicarbonate/Carbon DioxideKHS · Traditional | 02/29/1996SE |
| K955300 | Total Bilirubin ProcedureCIG · Traditional | 12/20/1995SE |
| K952437 | Dma Glucose Hexokinase U.V. ProcedureCFR · Traditional | 10/03/1995SE |
| K946161 | Dma Total Cholesterol ProcedureCHH · Traditional | 08/23/1995SE |
| K946354 | Dma Unsaturated Iron Binding Capacity ProcedureJMO · Traditional | 05/08/1995SE |
| K946355 | Dma Albumin ProcedureCIX · Traditional | 03/01/1995SE |
Questions and answers
When was Data-Zyme Urea Nitrogen Reagent Set cleared by the FDA?
Data-Zyme Urea Nitrogen Reagent Set (K802061) received a 510(k) decision of Substantially Equivalent on September 26, 1980, 32 days after the submission was received.
What is the product code of K802061?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.