K083339 is an FDA 510(k) clearance for the DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS). This device is classified as a Cresolphthalein Complexone, Calcium (Class II - Special Controls, product code CIC).
Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on March 9, 2009, 117 days after receiving the submission on November 12, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K083339 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2008 |
| Decision Date | March 09, 2009 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CIC — Cresolphthalein Complexone, Calcium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1145 |