K770398 is an FDA 510(k) clearance for the MINICON. This device is classified as a Clinical Sample Concentrator (Class I - General Controls, product code JJH).
Submitted by Amicon, Inc. (Walker, US). The FDA issued a Cleared decision on April 6, 1977, 35 days after receiving the submission on March 2, 1977.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.2310.
| 510(k) Number | K770398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 1977 |
| Decision Date | April 06, 1977 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JJH — Clinical Sample Concentrator |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2310 |