The following data is part of a premarket notification filed by Axis Biochemicals, Asa with the FDA for Axis Homocysteine Enzyme Immunoassay.
| Device ID | K980907 |
| 510k Number | K980907 |
| Device Name: | AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY |
| 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 |
| Subsequent Product Code | DFC |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-10 |
| Decision Date | 1998-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727014580 | K980907 | 000 |
| 00817439020925 | K980907 | 000 |
| 05055845400022 | K980907 | 000 |
| 05055845400015 | K980907 | 000 |