Total Iron Binding Capacity (Ibct) Flex Reagent Cartridge
FDA 510(k) K994115 · Dade Behring, Inc.
510(k) numberK994115
Submission
- Device name
- Total Iron Binding Capacity (Ibct) Flex Reagent Cartridge
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- December 6, 1999
- Decision date
- January 28, 2000
- 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
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|---|---|---|---|
| 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 |
| 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 |
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Questions and answers
When was Total Iron Binding Capacity (Ibct) Flex Reagent Cartridge cleared by the FDA?
Total Iron Binding Capacity (Ibct) Flex Reagent Cartridge (K994115) received a 510(k) decision of Substantially Equivalent on January 28, 2000, 53 days after the submission was received.
What is the product code of K994115?
The FDA product code is JMO – Ferrozine (Colorimetric) Iron Binding Capacity, a Class I (low risk) device regulated under 21 CFR 862.1415.