Dart Iron & Iron Binding Capacity Reagent
FDA 510(k) K854305 · Coulter Electronics, Inc.
510(k) numberK854305
Submission
- Device name
- Dart Iron & Iron Binding Capacity Reagent
- Applicant
- Coulter Electronics, Inc.
Hialeah, FL, US - Received
- October 25, 1985
- Decision date
- November 12, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CFM – Bathophenanthroline, Colorimetry, Iron (Non-Heme)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1410
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CFM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K984119 | Wako L-Type Fe, Wako L-Type CalibratorCFM · Traditional | Wako Chemicals USA, Inc. | 01/15/1999SE |
| K981581 | IronCFM · Traditional | Abbott Laboratories | 06/08/1998SE |
| K932871 | Uibc for Discreet Random Access AnalyzerCFM · Traditional | Catachem, Inc. | 09/08/1993SE |
| K913705 | Abbott Qluickstart Iron Test, Item #5A29CFM · Traditional | Em Diagnostic Systems, Inc. | 10/09/1991SE |
| K912912 | Synermed Serum IRON-600 Reagent KitCFM · Traditional | Synermed, Inc. | 07/30/1991SE |
| K902918 | Synermed Serum Iron Reagent KitCFM · Traditional | Synermed, Inc. | 07/31/1990SE |
| K895047 | Clinistat Potassium Reagent TestCFM · Traditional | Heraeus Kulzer, Inc. | 10/17/1989SE |
| K891155 | Iron ReagentCFM · Traditional | Medical Analysis Systems, Inc. | 04/18/1989SE |
| K873120 | Abbott A-Gent Iron Reagent KitCFM · Traditional | Abbott Laboratories | 08/25/1987SE |
| K861602 | Total Iron Binding Capacity ProcedureCFM · Traditional | Data Medical Associates, Inc. | 05/23/1986SE |
More from Data Medical Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K923951 | CD8 Cytospheres KitMAM · Traditional | 04/25/1994SE |
| K930119 | Coulter Retic-C Cell ControlJPK · Traditional | 04/05/1993SE |
| K921279 | CD4 Cytospheres KitGKZ · Traditional | 12/29/1992SE |
| K923530 | Coulter Multi-Q-PrepGKH · Traditional | 10/14/1992SE |
| K922181 | Coulter MH009GKZ · Traditional | 08/17/1992SE |
| K922704 | Coulter Maxm W/ AutoloaderGKZ · Traditional | 07/27/1992SE |
| K921567 | Coulter MH017GKZ · Traditional | 07/06/1992SE |
| K912133 | PX Coulter(R) Cell ControlJPK · Traditional | 07/17/1991SE |
| K911385 | Coulter(R) MH010GKZ · Traditional | 06/17/1991SE |
| K905771 | Coulter Dart Ast (Got) ReagentCIT · Traditional | 02/26/1991SE |
Questions and answers
When was Dart Iron & Iron Binding Capacity Reagent cleared by the FDA?
Dart Iron & Iron Binding Capacity Reagent (K854305) received a 510(k) decision of Substantially Equivalent on November 12, 1985, 18 days after the submission was received.
What is the product code of K854305?
The FDA product code is CFM – Bathophenanthroline, Colorimetry, Iron (Non-Heme), a Class I (low risk) device regulated under 21 CFR 862.1410.