The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for B12 Reagent Cartridge And Fol Flex Reagent Cartridge, Model Rf642 And Rf644.
| Device ID | K093631 |
| 510k Number | K093631 |
| Device Name: | B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 |
| Classification | Radioassay, Vitamin B12 |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 514 Newark, DE 19702 |
| Contact | Anna Marie Kathleen Ennis |
| Correspondent | Anna Marie Kathleen 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-24 |
| Decision Date | 2010-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414976617 | K093631 | 000 |