K863059 is an FDA 510(k) clearance for the CALCIOMETER. This device is classified as a Methylthymol Blue, Calcium (Class II - Special Controls, product code CIA).
Submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on September 26, 1986, 45 days after receiving the submission on August 12, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K863059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 1986 |
| Decision Date | September 26, 1986 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CIA — Methylthymol Blue, Calcium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1145 |