Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension Vista Sysyem
FDA 510(k) K081249 · Dade Behring, Inc.
510(k) numberK081249
Submission
- Device name
- Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension Vista Sysyem
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- May 2, 2008
- Decision date
- July 21, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DEB – Alpha-2-Macroglobulin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5620
- Specialty
- Immunology
Other 510(k)s with product code DEB
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|---|---|---|---|
| K140664 | Human ALPHA2-MACROGLOBULIN Kit for Use on SpaplusDEB · Traditional | The Binding Site Group , Ltd. | 04/16/2014SE |
| K053073 | N Antisera to Human ALPHA2-MACROGLOBULINDEB · Traditional | Dade Behring, Inc. | 03/28/2006SE |
| K974564 | Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional | Beckman Instruments, Inc. | 02/17/1998SE |
| K914389 | ALPHA-2 Macroglobulin Test Rid KitDEB · Traditional | The Binding Site, Ltd. | 12/20/1991SE |
| K896483 | QM300 ALPHA2 Macroglobulin Antibody PackDEB · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 12/01/1989SE |
| K850683 | 72 Determ. Size Radial Immunodiffusion Test ALPHA2DEB · Traditional | Kent Laboratories, Inc. | 11/27/1985SE |
| K851282 | Radial Immunodiffusion Plates ALPHA-2 MacroglobuliDEB · Traditional | Cooper Biomedical, Inc. | 05/24/1985SE |
| K850603 | SPQ Test System for ALPHA(2) MacroglobulinDEB · Traditional | Applications Lab | 03/05/1985SE |
| K812493 | Immunogl. Frct. of Rabbit Antiser.-MacroDEB · Traditional | Dako Corp. | 09/23/1981SE |
| K791340 | Human ALPHA2 MacroglobulinDEB · Traditional | Beckman Instruments, Inc. | 08/16/1979SE |
More from Beckman Instruments, Inc.
| 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 |
| 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 |
| K072717 | Dimension Vista System Bilirubin Calibrator, Model KC210JIT · Traditional | 12/12/2007SE |
Questions and answers
When was Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension Vista Sysyem cleared by the FDA?
Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension Vista Sysyem (K081249) received a 510(k) decision of Substantially Equivalent on July 21, 2008, 80 days after the submission was received.
What is the product code of K081249?
The FDA product code is DEB – Alpha-2-Macroglobulin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5620.