K123320 is an FDA 510(k) clearance for the DIMENSION AMMONIA FLEX REAGENT CARTRIDGE. This device is classified as a Enzymatic Method, Ammonia (Class I - General Controls, product code JIF).
Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on February 15, 2013, 112 days after receiving the submission on October 26, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1065.
| 510(k) Number | K123320 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2012 |
| Decision Date | February 15, 2013 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIF — Enzymatic Method, Ammonia |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1065 |