K894914 is an FDA 510(k) clearance for the MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK. This device is classified as a Electrode, Ion Specific, Sodium (Class II - Special Controls, product code JGS).
Submitted by I-Stat Corp. (Princeton, US). The FDA issued a Cleared decision on October 16, 1989, 75 days after receiving the submission on August 2, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K894914 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 1989 |
| Decision Date | October 16, 1989 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JGS — Electrode, Ion Specific, Sodium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1665 |