Submission Details
| 510(k) Number | K901964 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 01, 1990 |
| Decision Date | May 31, 1990 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
K901964 is an FDA 510(k) clearance for the PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463, a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I — General Controls, product code CEO), submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on May 31, 1990, 30 days after receiving the submission on May 1, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1580.
| 510(k) Number | K901964 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 01, 1990 |
| Decision Date | May 31, 1990 |
| Days to Decision | 30 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 |