Synermed Uibc Reagent Kit
FDA 510(k) K922784 · Synermed, Inc.
510(k) numberK922784
Submission
- Device name
- Synermed Uibc Reagent Kit
- Applicant
- Synermed, Inc.
Quebec, Canada, CA - Received
- June 9, 1992
- Decision date
- July 21, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| 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 |
|---|---|---|
| K973109 | Synermed Near-Infrared Direct Bilirubin Reagent KitCIG · Traditional | 09/25/1997SE |
| K972716 | Synermed Total Bilirubin Reagent KitCIG · Traditional | 08/07/1997SE |
| K971491 | Synermed Ir 200 Chemistry AnalyzerJJF · Traditional | 06/26/1997SE |
| K962479 | Synermed Ise ReagentsCGZ · Traditional | 03/03/1997SE |
| K963939 | Synermed Direct Bilirubin Reagent KitCIG · Traditional | 12/18/1996SE |
| K960793 | Synermed Enzymatic CO2 Reagent KitKHS · Traditional | 03/11/1996SE |
| K953395 | Synermed Calcium Reagent KitCJY · Traditional | 08/31/1995SE |
| K952179 | Synermed Ise ReagentsJGS · Traditional | 06/20/1995SE |
| K943924 | Creatinine-Po Reagent KitCGX · Traditional | 09/20/1994SE |
| K941091 | Synermed Amylase Reagent KitJFJ · Traditional | 05/03/1994SE |
Questions and answers
When was Synermed Uibc Reagent Kit cleared by the FDA?
Synermed Uibc Reagent Kit (K922784) received a 510(k) decision of Substantially Equivalent on July 21, 1992, 42 days after the submission was received.
What is the product code of K922784?
The FDA product code is JMO – Ferrozine (Colorimetric) Iron Binding Capacity, a Class I (low risk) device regulated under 21 CFR 862.1415.