K892645 is an FDA 510(k) clearance for the AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY. This device is classified as a System, Suspension, Cell Culture (Class I — General Controls, product code KJF).
Submitted by Amicon, Inc. (Danvers, US). The FDA issued a Cleared decision on June 13, 1989, 62 days after receiving the submission on April 12, 1989.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.2240.
| 510(k) Number | K892645 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 1989 |
| Decision Date | June 13, 1989 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | KJF — System, Suspension, Cell Culture |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 864.2240 |