Quickstart Urea Nitrogen
FDA 510(k) K914903 · Em Diagnostic Systems, Inc.
510(k) numberK914903
Submission
- Device name
- Quickstart Urea Nitrogen
- Applicant
- Em Diagnostic Systems, Inc.
Gibbstown, NJ, US - Received
- November 1, 1991
- Decision date
- December 31, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CDN – Urease, Photometric, Urea Nitrogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1770
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K190326 | VITROS XT Chemistry Products UREA-CREA SlidesCDN · Traditional | Ortho-Clinical Diagnostics, Inc. | 03/14/2019SE |
| K132462 | S Test Reagent Cartridge Bun and S Test Reagent Cartridge CreCDN · Traditional | Hitachi Chemical Diagnostics, Inc. | 10/28/2013SE |
| K123322 | Ace Bun/Urea Reagent, Ace Creatinine Reagent, Ace Uric Acid Reagent, Ace CK ReagentCDN · Traditional | Alfa Wassermann Diagnostics Technologies, LLC | 05/21/2013SE |
| K113389 | Ace CK Reagent,Ace Bun/Urea Reagent,Ace Uric Acid Reagent,Ace Creatinine ReagentCDN · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 08/10/2012SE |
| K103615 | Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent, Inorganic…CDN · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 09/08/2011SE |
| K001885 | Vitros Chemistry Products Bun/Urea Slides and Vitros Chemistry Products Calibrator Kit 1CDN · Special | Ortho-Clinical Diagnostics, Inc. | 07/20/2000SE |
| K972012 | Cholestech Bun/Creatinine Test SystemCDN · Traditional | Cholestech Corp. | 07/24/1997SE |
| K961196 | Ektachem Clinical Chemistry Urea Nitrogen/Urea (Bun/Urea)CDN · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 05/15/1996SE |
| K943042 | Bun QvetCDN · Traditional | Prisma Systems | 12/29/1994SE |
| K922969 | King Diagnostics Urea Nitrogen ReagentCDN · Traditional | King Diagnostics, Inc. | 10/13/1992SE |
More from King Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K935181 | Aspartate Aminotransferase (Ast) TestCIT · Traditional | 01/27/1994SE |
| K935180 | Alanine Aminotransferase (Alt) TestCKA · Traditional | 01/13/1994SE |
| K935179 | Emds Albumin (Alb) TestCIX · Traditional | 12/17/1993SE |
| K935178 | Emds Phosphorous (Phos) TestCEO · Traditional | 12/17/1993SE |
| K935177 | Gamma-Glutamyl Transferase (GGT) TestJQB · Traditional | 12/16/1993SE |
| K935176 | Iron TestJIY · Traditional | 12/16/1993SE |
| K935175 | Lactate Dehydrogenase (LD)CFJ · Traditional | 12/16/1993SE |
| K935174 | Total Protein Test (Tpro)CEK · Traditional | 12/16/1993SE |
| K935136 | Cholesterol (Chol) Test Item No. 65410CHH · Traditional | 12/16/1993SE |
| K935183 | Emds Magnesium (MG) TestJGJ · Traditional | 12/09/1993SE |
Questions and answers
When was Quickstart Urea Nitrogen cleared by the FDA?
Quickstart Urea Nitrogen (K914903) received a 510(k) decision of Substantially Equivalent on December 31, 1991, 60 days after the submission was received.
What is the product code of K914903?
The FDA product code is CDN – Urease, Photometric, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.