Vitros Chemistry Products Bun/Urea Slides and Vitros Chemistry Products Calibrator Kit 1
FDA 510(k) K001885 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK001885
Submission
- Device name
- Vitros Chemistry Products Bun/Urea Slides and Vitros Chemistry Products Calibrator Kit 1
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- June 21, 2000
- Decision date
- July 20, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|---|
| 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 |
| 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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| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA · Traditional | 05/08/2024SE |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent PackCEW · Traditional | 09/05/2023SE |
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| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent PackNIG · Traditional | 08/09/2023SE |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent PackLTK · Traditional | 12/12/2022SE |
| K213626 | Vitros AfpLOJ · Traditional | 06/15/2022SE |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent PackJHX · Traditional | 01/28/2022SE |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent PackNBC · Traditional | 10/04/2021SE |
Questions and answers
When was Vitros Chemistry Products Bun/Urea Slides and Vitros Chemistry Products Calibrator Kit 1 cleared by the FDA?
Vitros Chemistry Products Bun/Urea Slides and Vitros Chemistry Products Calibrator Kit 1 (K001885) received a 510(k) decision of Substantially Equivalent on July 20, 2000, 29 days after the submission was received.
What is the product code of K001885?
The FDA product code is CDN – Urease, Photometric, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.