Urea Nitrogen (Enzymatic)
FDA 510(k) K780534 · Macomb Chemical Co.
510(k) numberK780534
Submission
- Device name
- Urea Nitrogen (Enzymatic)
- Applicant
- Macomb Chemical Co.
Mchenry, IL, US - Received
- April 3, 1978
- Decision date
- May 19, 1978
- 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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| K140690 | BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry AnalyzerCDQ · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 09/02/2014SE |
| K110675 | Easyra Urea Nitrogen and Creatinine ReagentsCDQ · Traditional | Medica Corp. | 04/21/2011SE |
| K073295 | Urea/Bun, Scal, Nortrol, AbtrolCDQ · Traditional | Thermofisher Scientific OY | 05/29/2008SE |
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| K060120 | Teco CX3 Reagent Set for Synchron CX SystemCDQ · Traditional | Teco Diagnostics | 03/27/2006SE |
| K041051 | Raichem Bun Rate Reagent (Liquid)CDQ · Traditional | Hemagen Diagnostics, Inc. | 06/30/2004SE |
| 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 |
More from Hemagen Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K830095 | Rapid Chem Analyzer IIJJF · Traditional | 01/28/1983SE |
| K823720 | SpectrophotometerJJQ · Traditional | 01/07/1983SE |
| K810958 | GlycohemoglobinLCP · Traditional | 09/16/1981SE |
| K801086 | P-Nitrophenyl Phosphate · Traditional | 05/28/1980SE |
| K800719 | Enzymatic Urea Nitrogen Reagent Set ReviCDQ · Traditional | 05/08/1980SE |
| K800720 | Macomb Nad-Nicotinamide Adenine Dinucleo · Traditional | 04/21/1980SE |
| K792533 | Creatine Phosphokinase (CPK) Reagent SetJHW · Traditional | 01/11/1980SE |
| K792532 | Glucose (Hexokinase) Reagent SetCFR · Traditional | 01/11/1980SE |
| K791669 | Glucose Oxidase Reagent SetCGA · Traditional | 09/24/1979SE |
| K791511 | Enzymatic Reagent Set, 4X250 Ml.CHH · Traditional | 09/04/1979SE |
Questions and answers
When was Urea Nitrogen (Enzymatic) cleared by the FDA?
Urea Nitrogen (Enzymatic) (K780534) received a 510(k) decision of Substantially Equivalent on May 19, 1978, 46 days after the submission was received.
What is the product code of K780534?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.