Kolplast Cervical Sample Collection Kit— 510(k) K153128

Name: FDA 510(k) clearance K153128
Creator: U.S. Food and Drug Administration
Published: 2017-01-13

Substantially Equivalent

Kolplast CI SA

FDA 510(k) clearance K153128 for Kolplast Cervical Sample Collection Kit, Substantially Equivalent on 2017-01-13. Applicant: Kolplast CI SA. Device class: 2.

Clearance details

Applicant: Kolplast CI SA
Product code: Code HHT
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2015-10-29
Decision date: 2017-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Itupeva- Sp, BR

Download summary PDF View on FDA.gov ↗

Recent devices under product code HHT

view all

K182049 — exCellerator Cervical Collection Device2019-04-25
K141057 — DISPOSABLE CERVICAL BRUSH2015-05-14
K111681 — HISTOBRUSH2012-01-19
K083012 — PAPCONE2009-04-09
K081522 — BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY2008-12-05

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