Dimension Vista B2MIC Flex Reagent Cartridge, Protein 1 Calibrator, Control Medium, Control High
FDA 510(k) K063272 · Dade Behring, Inc.
510(k) numberK063272
Submission
- Device name
- Dimension Vista B2MIC Flex Reagent Cartridge, Protein 1 Calibrator, Control Medium, Control High
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- October 30, 2006
- Decision date
- January 26, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JZG – System, Test, Beta-2-Microglobulin Immunological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5630
- Specialty
- Immunology
Other 510(k)s with product code JZG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161297 | Beta-2-MicroglobulinJZG · Special | Beckman Coulter Ireland, Inc. | 06/07/2016SE |
| K122066 | Human BETA-2 Microglobulin Urine Kit for Use on the SpaplusJZG · Special | The Binding Site Group , Ltd. | 08/30/2012SE |
| K110874 | Advia Chemistry Reagents, and Advia Chemistry B2-MICROGLOBULIN CalibratorJZG · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/20/2012SE |
| K083289 | Human BETA-2 Microglobulin KitJZG · Traditional | The Binding Site, Ltd. | 05/06/2009SE |
| K083463 | Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension…JZG · Traditional | Siemens Healthcare Diagnostics | 03/13/2009SE |
| K072078 | Quantia BETA-2 Microglobulin, Model: 302822307JZG · Traditional | Biokit, S.A. | 12/19/2007SE |
| K050613 | Quantia BETA-2 MicroglobulinJZG · Traditional | Biokit, S.A. | 08/16/2005SE |
| K032692 | Dakocytomation BETA-2-MICROGLOBULIN Kit, Code No. Oa 368JZG · Traditional | Dako A/S | 01/22/2004SE |
| K014270 | Minineph Human B2-MICROGLOBULIN KitJZG · Traditional | The Binding Site, Ltd. | 08/15/2002SE |
| K002731 | N Latex B2-MICROGLOBULINJZG · Traditional | Dade Behring, Inc. | 11/20/2000SE |
More from Dade Behring, 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 |
| 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 B2MIC Flex Reagent Cartridge, Protein 1 Calibrator, Control Medium, Control High cleared by the FDA?
Dimension Vista B2MIC Flex Reagent Cartridge, Protein 1 Calibrator, Control Medium, Control High (K063272) received a 510(k) decision of Substantially Equivalent on January 26, 2007, 88 days after the submission was received.
What is the product code of K063272?
The FDA product code is JZG – System, Test, Beta-2-Microglobulin Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5630.