K894476 is an FDA 510(k) clearance for the CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION. This device is classified as a Azo Dye, Calcium (Class II - Special Controls, product code CJY).
Submitted by Catachem, Inc. (Port Chester, US). The FDA issued a Cleared decision on October 12, 1989, 86 days after receiving the submission on July 18, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K894476 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 1989 |
| Decision Date | October 12, 1989 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CJY — Azo Dye, Calcium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1145 |