The following data is part of a premarket notification filed by Anticancer Inc with the FDA for A/c Portable Enzymatic Homocysteine Assay.
| Device ID | K080851 |
| 510k Number | K080851 |
| Device Name: | A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY |
| Classification | Urinary Homocystine (nonquantitative) Test System |
| Applicant | ANTICANCER INC 7917 OSTROW ST. San Diego, CA 92111 |
| Contact | Yuying Tan |
| Correspondent | Yuying Tan ANTICANCER INC 7917 OSTROW ST. San Diego, CA 92111 |
| Product Code | LPS |
| CFR Regulation Number | 862.1377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-26 |
| Decision Date | 2008-10-10 |
| Summary: | summary |