K123930 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III. 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 May 15, 2013, 146 days after receiving the submission on December 20, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1377.
| 510(k) Number | K123930 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2012 |
| Decision Date | May 15, 2013 |
| Days to Decision | 146 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 |