K761138 is an FDA 510(k) clearance for the FA TISSUE FIXATIVE & WASH SET. This device is classified as a Fixative, Alcohol Containing (Class I - General Controls, product code LDZ).
Submitted by Zeus Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 6, 1978, 406 days after receiving the submission on November 26, 1976.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.4010.
| 510(k) Number | K761138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 1976 |
| Decision Date | January 06, 1978 |
| Days to Decision | 406 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | LDZ — Fixative, Alcohol Containing |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.4010 |