The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Vista Immunoglobulin A Flex Reagent Cartridge (iga), And Dimension Vista Immunoglobulin M Flex Reagent Cartrid.
| Device ID | K090594 |
| 510k Number | K090594 |
| Device Name: | DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Kathleen A Dray-lyons |
| Correspondent | Kathleen A Dray-lyons SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | CFN |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-05 |
| Decision Date | 2009-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768006197 | K090594 | 000 |
| 00842768006166 | K090594 | 000 |