Submission Details
| 510(k) Number | K962574 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 01, 1996 |
| Decision Date | July 22, 1996 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
K962574 is an FDA 510(k) clearance for the WATERS 474 SCANNING FLOURESCENCE DETECTOR (474), a Detectors, Electrochemical, Liquid Chromatography (Class I — General Controls, product code LEQ), submitted by Waters Corporation (Milford, US). The FDA issued a Cleared decision on July 22, 1996, 21 days after receiving the submission on July 1, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2260.
| 510(k) Number | K962574 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 01, 1996 |
| Decision Date | July 22, 1996 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | LEQ — Detectors, Electrochemical, Liquid Chromatography |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.2260 |