Submission Details
| 510(k) Number | K910296 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 23, 1991 |
| Decision Date | February 27, 1991 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
K910296 is an FDA 510(k) clearance for the PHOSPHORUS (INORGANIC) TEST SYSTEM, a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I — General Controls, product code CEO), submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on February 27, 1991, 35 days after receiving the submission on January 23, 1991. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1580.
| 510(k) Number | K910296 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 23, 1991 |
| Decision Date | February 27, 1991 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | CEO — Phosphomolybdate (colorimetric), Inorganic Phosphorus |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1580 |