K881361 is an FDA 510(k) clearance for the SOLID PHASE EXTRACTION TUBES. This device is classified as a Ion-exchange Chromatography (Class I - General Controls, product code DJY).
Submitted by Supelco, Inc. (Bellefonte, US). The FDA issued a Cleared decision on August 8, 1988, 174 days after receiving the submission on February 16, 1988.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2230.
| 510(k) Number | K881361 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 1988 |
| Decision Date | August 08, 1988 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DJY — Ion-exchange Chromatography |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2230 |