Iron Reagents Product Codes 7725 and 7726
FDA 510(k) K901960 · American Research Products Co.
510(k) numberK901960
Submission
- Device name
- Iron Reagents Product Codes 7725 and 7726
- Applicant
- American Research Products Co.
Solon, OH, US - Received
- May 1, 1990
- Decision date
- May 31, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K113438 | Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase…JMO · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 06/01/2012SE |
| 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 |
More from A.P. Total Care, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K942984 | Bun ReagentCDQ · Traditional | 03/01/1995SE |
| K901527 | Biuret (Colormetric), Total ProteinCEK · Traditional | 07/19/1990SE |
| K901964 | Phosphorus Reagents Prod Codes 7763/7764/7563/7463CEO · Traditional | 05/31/1990SE |
| K900827 | Colorimetric Chloride Product #4314125CHI · Traditional | 05/02/1990SE |
| K901702 | Nad Reduction, Alt/Spgt Codes 7722,7723,7422,7522CKA · Traditional | 04/25/1990SE |
| K900667 | Amresco Ldh-L Reagents Products #7710, 7711CFJ · Traditional | 04/19/1990SE |
| K900666 | Amresco Creatinine Reagents Product #7790, 7791CGX · Traditional | 04/19/1990SE |
| K900571 | Amresco Product Number 7728 (Bilirubin DPD)CIG · Traditional | 04/16/1990SE |
| K900977 | Amresco Inorganic Phosphorus Product #4312500CEO · Traditional | 04/11/1990SE |
| K900394 | Amresco Bun-Kinetic Reagents Products #7583CDQ · Traditional | 04/11/1990SE |
Questions and answers
When was Iron Reagents Product Codes 7725 and 7726 cleared by the FDA?
Iron Reagents Product Codes 7725 and 7726 (K901960) received a 510(k) decision of Substantially Equivalent on May 31, 1990, 30 days after the submission was received.
What is the product code of K901960?
The FDA product code is JMO – Ferrozine (Colorimetric) Iron Binding Capacity, a Class I (low risk) device regulated under 21 CFR 862.1415.