K113521 is an FDA 510(k) clearance for the CALCIUM GEN. 2. This device is classified as a Titrimetric With Edta And Indicator, Calcium (Class II - Special Controls, product code CHW).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on May 8, 2012, 161 days after receiving the submission on November 29, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K113521 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2011 |
| Decision Date | May 08, 2012 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CHW — Titrimetric With Edta And Indicator, Calcium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1145 |