Submission Details
| 510(k) Number | K903647 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 09, 1990 |
| Decision Date | September 11, 1990 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
K903647 is an FDA 510(k) clearance for the MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE, a Instrumentation, High Pressure Liquid Chromatography (Class I — General Controls, product code LDM), submitted by Millipore Corp. (Milford, US). The FDA issued a Cleared decision on September 11, 1990, 33 days after receiving the submission on August 9, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2260.
| 510(k) Number | K903647 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 09, 1990 |
| Decision Date | September 11, 1990 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LDM — Instrumentation, High Pressure Liquid Chromatography |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.2260 |