The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Dimension Vista Loci 9 Calibrator- Loci 9 Cal.
| Device ID | K113373 |
| 510k Number | K113373 |
| Device Name: | DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL |
| Classification | Calibrator, Secondary |
| Applicant | Siemens Healthcare Diagnostics Inc. PO BOX 6101 MAILSTOP 514 Newark, DE 19714 -6101 |
| Contact | Frances A Dillon |
| Correspondent | Frances A Dillon Siemens Healthcare Diagnostics Inc. PO BOX 6101 MAILSTOP 514 Newark, DE 19714 -6101 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-16 |
| Decision Date | 2011-12-30 |
| Summary: | summary |