The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Vista Immunoglobulin Igg Subclasss 1flex Reagent Cartridge, Dimension Vista Immunoglobulin Igg.
| Device ID | K092283 |
| 510k Number | K092283 |
| Device Name: | DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG |
| Classification | Igg (gamma Chain Specific), Antigen, Antiserum, Control |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 514 Newark, DE 19702 |
| Contact | Kathleen Ann Dray-lyons |
| Correspondent | Kathleen Ann Dray-lyons SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 514 Newark, DE 19702 |
| Product Code | DFZ |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-29 |
| Decision Date | 2009-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768006296 | K092283 | 000 |
| 00842768006289 | K092283 | 000 |
| 00842768006272 | K092283 | 000 |
| 00842768006265 | K092283 | 000 |