K860639 is an FDA 510(k) clearance for the IONIZED CALCIUM AND BLOOD PH TESTCARDS. This device is classified as a Electrode, Ion Specific, Calcium (Class II - Special Controls, product code JFP).
Submitted by Ilex Corp. (Attleboro, US). The FDA issued a Cleared decision on April 21, 1986, 60 days after receiving the submission on February 20, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K860639 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 1986 |
| Decision Date | April 21, 1986 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JFP — Electrode, Ion Specific, Calcium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1145 |