K032012 is an FDA 510(k) clearance for the HOMOCYSTEINE MICROTITER PLATE ASSAY. This device is classified as a Urinary Homocystine (nonquantitative) Test System (Class II - Special Controls, product code LPS).
Submitted by Diazyme Laboratories (Irvine, US). The FDA issued a Cleared decision on September 3, 2003, 65 days after receiving the submission on June 30, 2003.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1377.
| 510(k) Number | K032012 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2003 |
| Decision Date | September 03, 2003 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LPS — Urinary Homocystine (nonquantitative) Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1377 |