K870369 is an FDA 510(k) clearance for the CALCIUM REAGENT-METHYL THYMOL BLUE METHOD. This device is classified as a Methylthymol Blue, Calcium (Class II - Special Controls, product code CIA).
Submitted by Trace Scientific , Ltd. (Clayton, Vic 3168, AU). The FDA issued a Cleared decision on August 19, 1987, 203 days after receiving the submission on January 28, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K870369 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 1987 |
| Decision Date | August 19, 1987 |
| Days to Decision | 203 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 |