The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension Vista Protein 1 Control M.
| Device ID | K083463 |
| 510k Number | K083463 |
| Device Name: | DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Anna M Kathleen Ennis |
| Correspondent | Anna M Kathleen Ennis SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | JZG |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-24 |
| Decision Date | 2009-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768024443 | K083463 | 000 |
| 00842768006043 | K083463 | 000 |
| 00842768006340 | K083463 | 000 |
| 00842768006333 | K083463 | 000 |