K853938 is an FDA 510(k) clearance for the LX 300 TISSUE PROCESSOR. This device is classified as a Processor, Tissue, Automated (Class I - General Controls, product code IEO).
Submitted by Innovative Medical Systems, Inc. (Ivyland, US). The FDA issued a Cleared decision on October 10, 1985, 16 days after receiving the submission on September 24, 1985.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3875.
| 510(k) Number | K853938 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 1985 |
| Decision Date | October 10, 1985 |
| Days to Decision | 16 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 |