K963734 is an FDA 510(k) clearance for the ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS. This device is classified as a Electrode, Ion-specific, Chloride (Class II - Special Controls, product code CGZ).
Submitted by Alko Diagnostic Corp. (Holliston, US). The FDA issued a Cleared decision on October 24, 1996, 56 days after receiving the submission on August 29, 1996.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1170.
| 510(k) Number | K963734 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 1996 |
| Decision Date | October 24, 1996 |
| Days to Decision | 56 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 |