PAP SMEAR KIT— 510(k) K861389

Substantially Equivalent

Intl. Cytobrush, Inc.

FDA 510(k) clearance K861389 for PAP SMEAR KIT, Substantially Equivalent on 1986-05-02. Applicant: Intl. Cytobrush, Inc.. Device class: 2.

Clearance details

Applicant: Intl. Cytobrush, Inc.
Product code: Code HHT
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1986-04-14
Decision date: 1986-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hollywood, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HHT

K182049 — exCellerator Cervical Collection Device2019-04-25
K153128 — Kolplast Cervical Sample Collection Kit2017-01-13
K141057 — DISPOSABLE CERVICAL BRUSH2015-05-14
K111681 — HISTOBRUSH2012-01-19
K083012 — PAPCONE2009-04-09

More clearances from Intl. Cytobrush, Inc.

K897070 — ENDOBRUSH(TM) DEVICE; OMNIBRUSH1990-09-10
K895675 — PAP SMEAR TRAY1989-12-11
K862322 — CHLAMYDIA KIT, STD KIT1986-07-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.