K861389 is an FDA 510(k) clearance for the PAP SMEAR KIT. This device is classified as a Spatula, Cervical, Cytological (Class II - Special Controls, product code HHT).
Submitted by Intl. Cytobrush, Inc. (Hollywood, US). The FDA issued a Cleared decision on May 2, 1986, 18 days after receiving the submission on April 14, 1986.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K861389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 1986 |
| Decision Date | May 02, 1986 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HHT — Spatula, Cervical, Cytological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |