K831334 is an FDA 510(k) clearance for the TISSUE CASSETTES FOR PROCESSING-EM BED. This device is classified as a Cassettes, Tissue (Class I - General Controls, product code IDZ).
Submitted by Surgipath Medical Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 25, 1983, 30 days after receiving the submission on April 25, 1983.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3010.
| 510(k) Number | K831334 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 1983 |
| Decision Date | May 25, 1983 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | IDZ — Cassettes, Tissue |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.3010 |