Ektachem Clinical Chemistry Urea Nitrogen/Urea (Bun/Urea)
FDA 510(k) K961196 · Johnson & Johnson Clinical Diagnostics, Inc.
510(k) numberK961196
Submission
- Device name
- Ektachem Clinical Chemistry Urea Nitrogen/Urea (Bun/Urea)
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- March 27, 1996
- Decision date
- May 15, 1996
- 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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| 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 |
| 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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|---|---|---|
| K980283 | Vitros Chemistry Products CRBM SlidesKLT · Traditional | 02/25/1998SE |
| K974644 | Vitros Immunodiagnostic Products Range VerifiersJJX · Traditional | 01/13/1998SE |
| K973517 | Vitros Immunodiagnostic Products Range VerifiersJJY · Traditional | 09/25/1997SE |
| K973030 | Vitros Immunodiagnostics Products/Ck-Mb Reagent PACK(GEM.1300)/CK-MB Calibrators…JJY · Traditional | 09/04/1997SE |
| K972133 | Vitros Immunodiagnostics Products Progesterone Reagent Pack (GEM.1070), Progesterone…JLS · Traditional | 06/24/1997SE |
| K970894 | Vitros Immunodiagnostics Products Total B-Hcg Reagent Pack (GEM.1075), Total B-Hcg…DHA · Traditional | 04/14/1997SE |
| K970643 | Vitros Immunodiagnostics Products Estradiol Reagent Pack(Gem. 1050)/ESTRADIOL…CHP · Traditional | 03/18/1997SE |
| K965142 | Vitros Immunodiagnostics Products Free T4 Reagent Pack (GEM.1015) Free T4 Calibrators…CEC · Traditional | 03/18/1997SE |
| K970281 | Vitros Immunodiagnostic Products Prolactin Reagent Pack/CalibratorsCFT · Traditional | 02/25/1997SE |
| K964982 | Vitros Immunodiagnostics Products LH Reagent Pack (GEM.1055) and LH Calibrators (GEM.CO55)CEP · Traditional | 02/20/1997SE |
Questions and answers
When was Ektachem Clinical Chemistry Urea Nitrogen/Urea (Bun/Urea) cleared by the FDA?
Ektachem Clinical Chemistry Urea Nitrogen/Urea (Bun/Urea) (K961196) received a 510(k) decision of Substantially Equivalent on May 15, 1996, 49 days after the submission was received.
What is the product code of K961196?
The FDA product code is CDN – Urease, Photometric, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.