K830625 is an FDA 510(k) clearance for the CYTO-STAIN. This device is classified as a Stereoscope, Ac-powered (Class I - General Controls, product code HJQ).
Submitted by Richard-Allan Medical Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983, 23 days after receiving the submission on March 1, 1983.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 886.1870.
| 510(k) Number | K830625 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1983 |
| Decision Date | March 24, 1983 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | HJQ — Stereoscope, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1870 |