The following data is part of a premarket notification filed by Anticancer Inc with the FDA for A/c Enzymatic Vitamin B6 Assay.
| Device ID | K111260 |
| 510k Number | K111260 |
| Device Name: | A/C ENZYMATIC VITAMIN B6 ASSAY |
| Classification | Radioassay, Vitamin B12 |
| Applicant | ANTICANCER INC 7917 OSTROW ST. San Diego, CA 92111 |
| Contact | Qinghong Han |
| Correspondent | Qinghong Han ANTICANCER INC 7917 OSTROW ST. San Diego, CA 92111 |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-05 |
| Decision Date | 2012-07-26 |
| Summary: | summary |