PAP SMEAR KIT— 510(k) K862242

Substantially Equivalent

Quali-Med, Inc.

FDA 510(k) clearance K862242 for PAP SMEAR KIT, Substantially Equivalent on 1986-06-26. Applicant: Quali-Med, Inc.. Device class: 2.

Clearance details

Applicant: Quali-Med, Inc.
Product code: Code HHT
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1986-06-12
Decision date: 1986-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sugar Land, TX, 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 Quali-Med, Inc.

K871408 — BLOOD VESSEL CONNECTOR1987-04-27
K862972 — DISPOSABLE MIRROR1986-09-23
K862472 — QUARTZ RODS TITANIUM RODS1986-09-12
K862241 — STANDARD BASIN KIT CUSTOM BASIN KIT1986-08-01
K862172 — QUALI-MED'S OPERATING ROOM DRAPES1986-06-19

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