K003912 is an FDA 510(k) clearance for the PHOSPHORUS REAGENT. This device is classified as a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I - General Controls, product code CEO).
Submitted by Jas Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on February 21, 2001, 64 days after receiving the submission on December 19, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1580.
| 510(k) Number | K003912 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2000 |
| Decision Date | February 21, 2001 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CEO — Phosphomolybdate (colorimetric), Inorganic Phosphorus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1580 |