The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Vista Afp Flex Reagent Cartridge, Model 6454.
| Device ID | K090236 |
| 510k Number | K090236 |
| Device Name: | DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 |
| Classification | Kit, Test,alpha-fetoprotein For Testicular Cancer |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 514 Newark, DE 19702 |
| Contact | Janet M Fose |
| Correspondent | Janet M Fose SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 514 Newark, DE 19702 |
| Product Code | LOJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-02 |
| Decision Date | 2009-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768019937 | K090236 | 000 |