K792095 is an FDA 510(k) clearance for the HISTO-CENTER II. This device is classified as a Dispensers, Paraffin (Class I - General Controls, product code IDW).
Submitted by Thermolyne Corp. (Mchenry, US). The FDA issued a Cleared decision on November 20, 1979, 34 days after receiving the submission on October 17, 1979.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3010.
| 510(k) Number | K792095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 1979 |
| Decision Date | November 20, 1979 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | IDW — Dispensers, Paraffin |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.3010 |