K070531 is an FDA 510(k) clearance for the ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER. This device is classified as a Electrode, Ion-specific, Chloride (Class II - Special Controls, product code CGZ).
Submitted by Thermo Fisher Scientific (Pittsburgh, US). The FDA issued a Cleared decision on September 4, 2007, 193 days after receiving the submission on February 23, 2007.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1170.
| 510(k) Number | K070531 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2007 |
| Decision Date | September 04, 2007 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGZ — Electrode, Ion-specific, Chloride |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1170 |