K041643 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT. This device is classified as a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I - General Controls, product code CEO).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on August 18, 2004, 62 days after receiving the submission on June 17, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1580.
| 510(k) Number | K041643 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2004 |
| Decision Date | August 18, 2004 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CEO — Phosphomolybdate (colorimetric), Inorganic Phosphorus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1580 |