K013451 is an FDA 510(k) clearance for the PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES. This device is classified as a Electrode, Ion-specific, Chloride (Class II - Special Controls, product code CGZ).
Submitted by Phoenix Diagnostics, Inc. (Natick, US). The FDA issued a Cleared decision on December 18, 2001, 61 days after receiving the submission on October 18, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1170.
| 510(k) Number | K013451 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 2001 |
| Decision Date | December 18, 2001 |
| Days to Decision | 61 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 |