K770592 is an FDA 510(k) clearance for the CYTOLOGY FIXATIVE. This device is classified as a Preservative, Cytological (Class I - General Controls, product code LEA).
Submitted by Surgipath Medical Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 20, 1977, 53 days after receiving the submission on March 28, 1977.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.4010.
| 510(k) Number | K770592 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 1977 |
| Decision Date | May 20, 1977 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | LEA — Preservative, Cytological |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.4010 |