K792707 is an FDA 510(k) clearance for the PARA-PAK SAF. This device is classified as a Formaldehyde (formalin, Formol) (Class I - General Controls, product code IGG).
Submitted by Meridian Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1980, 25 days after receiving the submission on December 27, 1979.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.4010.
| 510(k) Number | K792707 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1979 |
| Decision Date | January 21, 1980 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | IGG — Formaldehyde (formalin, Formol) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.4010 |