Cleared Traditional

Kolplast Cervical Sample Collection Kit

K153128 · Kolplast CI SA · Pathology

Jan 2017

Decision

442d

Days

Class 2

Risk

About This 510(k) Submission

K153128 is an FDA 510(k) clearance for the Kolplast Cervical Sample Collection Kit, a Spatula, Cervical, Cytological (Class II — Special Controls, product code HHT), submitted by Kolplast CI SA (Itupeva- Sp, BR). The FDA issued a Cleared decision on January 13, 2017, 442 days after receiving the submission on October 29, 2015. This device falls under the Pathology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K153128 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 29, 2015
Decision Date	January 13, 2017
Days to Decision	442 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF