Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control Medium, and Protein 1 Control High
FDA 510(k) K063425 · Dade Behring, Inc.
510(k) numberK063425
Submission
- Device name
- Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control Medium, and Protein 1 Control High
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- November 13, 2006
- Decision date
- February 15, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DGC – Ige, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code DGC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231151 | Kenota 1 Total IgE; Kenota 1 (instrument)DGC · Dual Track | Kenota, Inc. | 05/31/2024SE |
| K214068 | Quantia IgEDGC · Special | Biokit, S.A. | 02/21/2023SE |
| K220178 | Total Immunoglobulin E (IgE)DGC · Traditional | Beckman Coulter, Inc. | 03/23/2022SE |
| K193493 | ADVIA Centaur Total IgE (tIgE)DGC · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/15/2020SE |
| K161899 | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE…DGC · Special | Phadia AB | 07/28/2016SE |
| K133404 | Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control LMHDGC · Special | Phadia AB | 02/24/2014SE |
| K050493 | Quantia IgeDGC · Traditional | Biokit, S.A. | 08/16/2005SE |
| K042241 | K-Assay Total Ige, K-Assay Ige Calibrator Set, Models KAI-092/KAI-093CDGC · Traditional | Kamiya Biomedical Co. | 12/10/2004SE |
| K034057 | LacrytestDGC · Traditional | Adiatec SA | 03/09/2004SE |
| K032251 | Immunetech Total Ige SystemDGC · Traditional | Immunetech Corporation | 12/19/2003SE |
More from Immunetech Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K093848 | Pt-Multi-Calibrator, Model OPAT07GGN · Traditional | 12/20/2010SE |
| K081161 | Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…CFN · Traditional | 07/28/2008SE |
| K081249 | Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1…DEB · Traditional | 07/21/2008SE |
| K071603 | Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)DHX · Traditional | 06/25/2008SE |
| K071597 | Dimension Vista (R) Afp Flex(R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci…LOJ · Traditional | 06/04/2008SE |
| K073604 | Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge…CEC · Traditional | 03/13/2008SE |
| K073561 | Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…CFN · Traditional | 02/26/2008SE |
| K073072 | Dimension Ahdl Flex Reagent Cartridge, Model: DF48BJHM · Traditional | 02/21/2008SE |
| K073055 | Dimension Enzymatic Creatinine Flex Reagent Cartridge with Model DF270JFY · Traditional | 01/03/2008SE |
| K072965 | Dimension Vista C1 in; Flex Reagent Cartridge, Cal, ConDBA · Traditional | 12/21/2007SE |
Questions and answers
When was Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control Medium, and Protein 1 Control High cleared by the FDA?
Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control Medium, and Protein 1 Control High (K063425) received a 510(k) decision of Substantially Equivalent on February 15, 2007, 94 days after the submission was received.
What is the product code of K063425?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.