Submission Details
| 510(k) Number | K881868 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 03, 1988 |
| Decision Date | August 29, 1988 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
K881868 is an FDA 510(k) clearance for the LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD, a Columns, Liquid Chromatography (Class I — General Controls, product code DPM), submitted by Supelco, Inc. (Bellefonte, US). The FDA issued a Cleared decision on August 29, 1988, 118 days after receiving the submission on May 3, 1988. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2260.
| 510(k) Number | K881868 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 03, 1988 |
| Decision Date | August 29, 1988 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DPM — Columns, Liquid Chromatography |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.2260 |