Total Iron-Binding Capacity Accesory
FDA 510(k) K832759 · Seragen Diagnostics, Inc.
510(k) numberK832759
Submission
- Device name
- Total Iron-Binding Capacity Accesory
- Applicant
- Seragen Diagnostics, Inc.
Mchenry, IL, US - Received
- August 19, 1983
- Decision date
- October 14, 1983
- 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 |
|---|---|---|
| K872148 | Vivid Chlamydia(Tm)LJC · Traditional | 08/19/1987SE |
| K851663 | Quick-Count Hematology ControlsJPK · Traditional | 07/23/1985SE |
| K852260 | Quick-Chem Calibration SetJIW · Traditional | 07/22/1985SE |
| K851520 | Ck/Ld Isoenzymes Controls(Human)JJT · Traditional | 06/25/1985SE |
| K851521 | LD-1(IMMUNO) Separation SetCEX · Traditional | 05/10/1985SE |
| K850209 | Quick-LyteJGS · Traditional | 02/27/1985SE |
| K844743 | Seratest Ena(Rnp/Sm) DeterminationLLL · Traditional | 02/04/1985SE |
| K842563 | Seratest DNA DeterminationLKJ · Traditional | 10/25/1984SE |
| K841504 | Quick-Count Plus 2GKL · Traditional | 06/11/1984SE |
| K840793 | Ck/Mb Immuno-Isoenzyme Control SerumJJT · Traditional | 04/13/1984SE |
Questions and answers
When was Total Iron-Binding Capacity Accesory cleared by the FDA?
Total Iron-Binding Capacity Accesory (K832759) received a 510(k) decision of Substantially Equivalent on October 14, 1983, 56 days after the submission was received.
What is the product code of K832759?
The FDA product code is JMO – Ferrozine (Colorimetric) Iron Binding Capacity, a Class I (low risk) device regulated under 21 CFR 862.1415.