K781582 is an FDA 510(k) clearance for the PAPANICOLAOU STAIN EA-36. This device is classified as a Stain, Papanicolau (Class I - General Controls, product code HZJ).
Submitted by Bioscientific (Mchenry, US). The FDA issued a Cleared decision on October 10, 1978, 22 days after receiving the submission on September 18, 1978.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1850.
| 510(k) Number | K781582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 1978 |
| Decision Date | October 10, 1978 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | HZJ — Stain, Papanicolau |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.1850 |