Submission Details
| 510(k) Number | K862506 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 01, 1986 |
| Decision Date | July 29, 1986 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
K862506 is an FDA 510(k) clearance for the THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR, a Apparatus, High Pressure Liquid Chromatography (Class I — General Controls, product code KIE), submitted by Millipore Corp. (Milford, US). The FDA issued a Cleared decision on July 29, 1986, 28 days after receiving the submission on July 1, 1986. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2260.
| 510(k) Number | K862506 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 01, 1986 |
| Decision Date | July 29, 1986 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | KIE — Apparatus, High Pressure Liquid Chromatography |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.2260 |