K881165 is an FDA 510(k) clearance for the SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR. This device is classified as a Processor, Tissue, Automated (Class I - General Controls, product code IEO).
Submitted by Sakura Finetek U.S.A., Inc. (Torrance, US). The FDA issued a Cleared decision on July 1, 1988, 103 days after receiving the submission on March 20, 1988.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3875.
| 510(k) Number | K881165 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 1988 |
| Decision Date | July 01, 1988 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | IEO — Processor, Tissue, Automated |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.3875 |