K061588 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS. This device is classified as a Urinary Homocystine (nonquantitative) Test System (Class II - Special Controls, product code LPS).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on July 21, 2006, 43 days after receiving the submission on June 8, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1377.
| 510(k) Number | K061588 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2006 |
| Decision Date | July 21, 2006 |
| Days to Decision | 43 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 |