The following data is part of a premarket notification filed by Axis Biochemicals, Asa with the FDA for Imx Homocysteine.
| Device ID | K980812 |
| 510k Number | K980812 |
| Device Name: | IMX HOMOCYSTEINE |
| Classification | Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Applicant | AXIS BIOCHEMICALS, ASA PO BOX 262069 San Diego, CA 92196 |
| Contact | Ronald G Leonardi, Ph.d. |
| Correspondent | Ronald G Leonardi, Ph.d. AXIS BIOCHEMICALS, ASA PO BOX 262069 San Diego, CA 92196 |
| Product Code | DFC |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-03 |
| Decision Date | 1998-10-01 |
| Summary: | summary |