The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Homocysteine Microtiter Plate Assay.
| Device ID | K032012 |
| 510k Number | K032012 |
| Device Name: | HOMOCYSTEINE MICROTITER PLATE ASSAY |
| Classification | Urinary Homocystine (nonquantitative) Test System |
| Applicant | DIAZYME LABORATORIES 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland DIAZYME LABORATORIES 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | LPS |
| CFR Regulation Number | 862.1377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-30 |
| Decision Date | 2003-09-03 |
| Summary: | summary |