The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Loci Vitamin B12 (vb12) Flex Reagent Cartridge, Loci Anemia Calibrator (anem Cal).
| Device ID | K133512 |
| 510k Number | K133512 |
| Device Name: | LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) |
| Classification | Radioassay, Vitamin B12 |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 514 Newark, DE 19702 |
| Contact | Anna Marie K Ennis |
| Correspondent | Anna Marie K Ennis SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 514 Newark, DE 19702 |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-15 |
| Decision Date | 2014-01-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414976631 | K133512 | 000 |
| 00630414976624 | K133512 | 000 |