The following data is part of a premarket notification filed by Axis Biochemicals, Asa with the FDA for Modification To Imx Homocysteine.
| Device ID | K992274 |
| 510k Number | K992274 |
| Device Name: | MODIFICATION TO IMX HOMOCYSTEINE |
| Classification | Urinary Homocystine (nonquantitative) Test System |
| Applicant | AXIS BIOCHEMICALS, ASA PO BOX 262069 San Diego, CA 92196 |
| Contact | Ronald G Leonardi |
| Correspondent | Ronald G Leonardi AXIS BIOCHEMICALS, ASA PO BOX 262069 San Diego, CA 92196 |
| Product Code | LPS |
| CFR Regulation Number | 862.1377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-06 |
| Decision Date | 1999-10-06 |
| Summary: | summary |