Dimension Vista Immunoglobulin Igg Subclasss 1FLEX Reagent Cartridge, Dimension Vista Immunoglobulin Igg
FDA 510(k) K092283 · Siemens Healthcare Diagnostics
510(k) numberK092283
Submission
- Device name
- Dimension Vista Immunoglobulin Igg Subclasss 1FLEX Reagent Cartridge, Dimension Vista Immunoglobulin Igg
- Applicant
- Siemens Healthcare Diagnostics
Newark, DE, US - Received
- July 29, 2009
- Decision date
- October 21, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DFZ – Igg (Gamma Chain Specific), Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code DFZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K021081 | Human Igg Subclass Liquid Reagent Kits for Use on the Hitachi 911/7070 Turbidimetric…DFZ · Traditional | The Binding Site, Ltd. | 06/17/2002SE |
| K020823 | Peliclass Human Igg Subclass Nephelometric Immage KitDFZ · Traditional | Sanquin Blood Supply Foundation | 05/14/2002SE |
| K955906 | Boehringer Mannheim Igg AssayDFZ · Traditional | Boehringer Mannheim Corp. | 02/09/1996SE |
| K940422 | Igg Subclass Single Dilution Diagnostic Kit for Use with the Beckman Array AnalyzerDFZ · Traditional | The Binding Site, Ltd. | 05/27/1994SE |
| K812821 | H-103 Igg, H-104 Iga, H-105 IgmDFZ · Traditional | Immulok, Inc. | 10/26/1981SE |
| K803272 | Automated Immunoprecipitin Method/IcgDFZ · Traditional | Icl Scientific | 01/26/1981SE |
| K790720 | Antisera to Rabbit ImmunoglobulinDFZ · Traditional | Kent Laboratories, Inc. | 08/16/1979SE |
| K790709 | Antiserum to Rabbit ImmunoglobulinDFZ · Traditional | Kent Laboratories, Inc. | 08/16/1979SE |
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Questions and answers
When was Dimension Vista Immunoglobulin Igg Subclasss 1FLEX Reagent Cartridge, Dimension Vista Immunoglobulin Igg cleared by the FDA?
Dimension Vista Immunoglobulin Igg Subclasss 1FLEX Reagent Cartridge, Dimension Vista Immunoglobulin Igg (K092283) received a 510(k) decision of Substantially Equivalent on October 21, 2009, 84 days after the submission was received.
What is the product code of K092283?
The FDA product code is DFZ – Igg (Gamma Chain Specific), Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.