K061296 is an FDA 510(k) clearance for the DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR. This device is classified as a Urinary Homocystine (nonquantitative) Test System (Class II - Special Controls, product code LPS).
Submitted by Diazyme Laboratories (San Diego, US). The FDA issued a Cleared decision on June 13, 2006, 35 days after receiving the submission on May 9, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1377.
| 510(k) Number | K061296 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2006 |
| Decision Date | June 13, 2006 |
| Days to Decision | 35 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | LPS — Urinary Homocystine (nonquantitative) Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1377 |