Iron Binding Capacity Chemistry
FDA 510(k) K780094 · Harleco
510(k) numberK780094
Submission
- Device name
- Iron Binding Capacity Chemistry
- Applicant
- Harleco
Mchenry, IL, US - Received
- January 18, 1978
- Decision date
- February 13, 1978
- 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 |
|---|---|---|
| K820233 | Ultrazyme Plus Gamma GT(65055-65056)JQB · Traditional | 02/12/1982SE |
| K813427 | Ultrachem Gluc-DhLFR · Traditional | 12/31/1981SE |
| K813044 | Ultrachem Alb, Item #64970CIX · Traditional | 11/10/1981SE |
| K813043 | Ultrachem Crea Item #64972CGX · Traditional | 11/10/1981SE |
| K813042 | Ultrachem Gluc-Dh Set, Item #65048LFR · Traditional | 11/10/1981SE |
| K813041 | Ultrazyme-Gt, Item #64959 & 65032JQB · Traditional | 11/10/1981SE |
| K813040 | Ultrachem Ca, Item #64975CJY · Traditional | 11/10/1981SE |
| K813039 | Ultrachem E-Chol, Item #65025CHH · Traditional | 11/10/1981SE |
| K813038 | Ultrachem TP, Item #64974CEK · Traditional | 11/10/1981SE |
| K812594 | Ultra Zyme Plus Amyl #64982 & 65031CIJ · Traditional | 10/02/1981SE |
Questions and answers
When was Iron Binding Capacity Chemistry cleared by the FDA?
Iron Binding Capacity Chemistry (K780094) received a 510(k) decision of Substantially Equivalent on February 13, 1978, 26 days after the submission was received.
What is the product code of K780094?
The FDA product code is JMO – Ferrozine (Colorimetric) Iron Binding Capacity, a Class I (low risk) device regulated under 21 CFR 862.1415.