The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Dimension Vista Vitamin B12 (vb12) Flex Reagent Cartridge, Dimension Vista Loci 4 Calibrator.
| Device ID | K121994 |
| 510k Number | K121994 |
| Device Name: | DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR |
| Classification | Radioassay, Vitamin B12 |
| Applicant | Siemens Healthcare Diagnostics Inc. 500 GBC DRIVE Newark, DE 19714 |
| Contact | A. Kathleen B Ennis |
| Correspondent | A. Kathleen B Ennis Siemens Healthcare Diagnostics Inc. 500 GBC DRIVE Newark, DE 19714 |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-06 |
| Decision Date | 2012-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768033827 | K121994 | 000 |
| 00842768033810 | K121994 | 000 |