Submission Details
| 510(k) Number | K123930 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
May 2013
Decision
146d
Days
Class 2
Risk
About This 510(k) Submission
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, 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 review panel. Regulated under 21 CFR 862.1377.
Device Classification
| Product Code | LPS — Urinary Homocystine (nonquantitative) Test System |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1377 |
Manufacturer
Similar Devices — LPS Urinary Homocystine (nonquantitative) Test System
All 28
K121053 · Diazyme Laboratories
· Jul 2012
K121533 · Tosoh Bioscience, Inc.
· Jun 2012
K113793 · Roche
· Jun 2012
K112790 · Axis-Shield Diagnostics, Ltd.
· May 2012
K083222 · Axis-Shield Diagnostics, Ltd.
· Jul 2009
K080851 · Anticancer, Inc.
· Oct 2008
More from Ortho-Clinical Diagnostics,...
View all
K252393
· MMI · Oct 2025
DEN210038
· QVP · May 2023
DEN210040
· QVP · May 2023
K210858
· DLZ · Aug 2021
K191316
· CIX · Jun 2019