VITROS XT Chemistry Products UREA-CREA Slides
FDA 510(k) K190326 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK190326
Submission
- Device name
- VITROS XT Chemistry Products UREA-CREA Slides
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- February 13, 2019
- Decision date
- March 14, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
Other 510(k)s with product code CDN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K914903 | Quickstart Urea NitrogenCDN · Traditional | Em Diagnostic Systems, Inc. | 12/31/1991SE |
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Questions and answers
When was VITROS XT Chemistry Products UREA-CREA Slides cleared by the FDA?
VITROS XT Chemistry Products UREA-CREA Slides (K190326) received a 510(k) decision of Substantially Equivalent on March 14, 2019, 29 days after the submission was received.
What is the product code of K190326?
The FDA product code is CDN – Urease, Photometric, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.