Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent, Inorganic Phosphorus U.V. Reagent,Urine Standard
FDA 510(k) K103615 · Alfa Wassermann Diagnostic Technologies, Inc.
510(k) numberK103615
Submission
- Device name
- Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent, Inorganic Phosphorus U.V. Reagent,Urine Standard
- Applicant
- Alfa Wassermann Diagnostic Technologies, Inc.
West Caldwell, NJ, US - Received
- December 9, 2010
- Decision date
- September 8, 2011
- 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
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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 |
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| 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 |
More from Em Diagnostic Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K170623 | ACE Hemoglobin A1c (HbA1c) ReagentLCP · Traditional | 02/27/2018SE |
| K131975 | Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace Ldh-L…CFJ · Traditional | 10/02/2013SE |
| K131351 | Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentCJE · Traditional | 08/15/2013SE |
| K123953 | Ace Carbon Dioxide Reagent, Ace Direct Biliubin Reagent, Ace Total Bilirubin Reagent…KHS · Traditional | 05/02/2013SE |
| K123018 | Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode…CFR · Traditional | 04/23/2013SE |
| K122757 | Ace Cholesterol Reagent, Ace Hdl-C Reagent, Ace Ldl-C Reagent, Ace Triglycerides ReagentCHH · Traditional | 10/05/2012SE |
| K113389 | Ace CK Reagent,Ace Bun/Urea Reagent,Ace Uric Acid Reagent,Ace Creatinine ReagentCDN · Traditional | 08/10/2012SE |
| K113437 | Ace Hemoglobin Alc(Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace…LCP · Traditional | 08/06/2012SE |
| K113374 | Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace…CIX · Traditional | 07/13/2012SE |
| K113262 | Ace Cholesterol Reagent, Ace Hdl-C Reagent, Ace Ldl-C Reagent-C, Ace-Trislycerides ReagentCHH · Traditional | 07/03/2012SE |
Questions and answers
When was Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent, Inorganic Phosphorus U.V. Reagent,Urine Standard cleared by the FDA?
Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent, Inorganic Phosphorus U.V. Reagent,Urine Standard (K103615) received a 510(k) decision of Substantially Equivalent on September 8, 2011, 273 days after the submission was received.
What is the product code of K103615?
The FDA product code is CDN – Urease, Photometric, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.