Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase Reagent
FDA 510(k) K113438 · Alfa Wassermann Diagnostic Technologies, Inc.
510(k) numberK113438
Submission
- Device name
- Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase Reagent
- Applicant
- Alfa Wassermann Diagnostic Technologies, Inc.
West Caldwell, NJ, US - Received
- November 21, 2011
- Decision date
- June 1, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JMO – Ferrozine (Colorimetric) Iron Binding Capacity
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1415
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JMO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061464 | Vitros Chemistry Products Tibc Kit, Model 886 7541; Calibrator Kit 4, Model 120 4668JMO · Special | Ortho-Clinical Diagnostics, Inc. | 06/15/2006SE |
| K052867 | Vitros Chemistry Products Dtibc ReagentJMO · Traditional | Ortho-Clinical Diagnostics, Inc. | 12/23/2005SE |
| K041793 | Olympus Unsaturated Iron Binding Capcity Reagent, OSR6124/0SR6524JMO · Special | Olympus America, Inc. | 07/16/2004SE |
| K013102 | Wiener Lab. Fer-Color Transferrina, Model Aux. Reagents for 25 Samples Cat. 1492002JMO · Traditional | Wiener Laboratories Saic | 11/13/2001SE |
| K012340 | Bayer Advia System; Unsaturated Iron Binding Capacity (Uibc)JMO · Traditional | Bayer Corp. | 10/01/2001SE |
| K000781 | Direct Tibc KitJMO · Traditional | Reference Diagnostics, Inc. | 05/02/2000SE |
| K994115 | Total Iron Binding Capacity (Ibct) Flex Reagent CartridgeJMO · Traditional | Dade Behring, Inc. | 01/28/2000SE |
| K991666 | Tibc, Product No's 123-0, 123-02, FE109-01, FE109-02JMO · Traditional | A.P. Total Care, Inc. | 06/30/1999SE |
| K991244 | Total Iron, Models Fe 109-01, Fe 109-02JMO · Traditional | A.P. Total Care, Inc. | 05/25/1999SE |
| K990216 | Magnetic Tibc KitJMO · Traditional | Reference Diagnostics, Inc. | 02/16/1999SE |
More from Reference Diagnostics, 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 Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase Reagent cleared by the FDA?
Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase Reagent (K113438) received a 510(k) decision of Substantially Equivalent on June 1, 2012, 193 days after the submission was received.
What is the product code of K113438?
The FDA product code is JMO – Ferrozine (Colorimetric) Iron Binding Capacity, a Class I (low risk) device regulated under 21 CFR 862.1415.