Submission Details
| 510(k) Number | K864267 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 29, 1986 |
| Decision Date | January 09, 1987 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
K864267 is an FDA 510(k) clearance for the SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY), a Columns, Liquid Chromatography (Class I — General Controls, product code DPM), submitted by Millipore Corp. (Milford, US). The FDA issued a Cleared decision on January 9, 1987, 72 days after receiving the submission on October 29, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2260.
| 510(k) Number | K864267 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 29, 1986 |
| Decision Date | January 09, 1987 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DPM — Columns, Liquid Chromatography |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.2260 |