K974607 is an FDA 510(k) clearance for the RANDOX CALCIUM. This device is classified as a Azo Dye, Calcium (Class II - Special Controls, product code CJY).
Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, IE). The FDA issued a Cleared decision on February 2, 1998, 54 days after receiving the submission on December 10, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K974607 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 1997 |
| Decision Date | February 02, 1998 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CJY — Azo Dye, Calcium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1145 |