Submission Details
| 510(k) Number | K844182 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 26, 1984 |
| Decision Date | November 09, 1984 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
K844182 is an FDA 510(k) clearance for the INORGANIC PHOSPHORUS REAGENT SET, a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I — General Controls, product code CEO), submitted by Livonia Diagnostics, Inc. (Livonia, US). The FDA issued a Cleared decision on November 9, 1984, 14 days after receiving the submission on October 26, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1580.
| 510(k) Number | K844182 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 26, 1984 |
| Decision Date | November 09, 1984 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CEO — Phosphomolybdate (colorimetric), Inorganic Phosphorus |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1580 |