K922835 is an FDA 510(k) clearance for the CALCIUM (AZ III) REAGENT. This device is classified as a Azo Dye, Calcium (Class II - Special Controls, product code CJY).
Submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on August 4, 1992, 53 days after receiving the submission on June 12, 1992.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K922835 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 1992 |
| Decision Date | August 04, 1992 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CJY — Azo Dye, Calcium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1145 |