Cleared Traditional

BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY

K081522 · Bio Nuclear Diagnostics, Inc. · Obstetrics & Gynecology

Dec 2008

Decision

189d

Days

Class 2

Risk

About This 510(k) Submission

K081522 is an FDA 510(k) clearance for the BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY, a Spatula, Cervical, Cytological (Class II — Special Controls, product code HHT), submitted by Bio Nuclear Diagnostics, Inc. (Toronto, Ontario, CA). The FDA issued a Cleared decision on December 5, 2008, 189 days after receiving the submission on May 30, 2008. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K081522 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2008
Decision Date	December 05, 2008
Days to Decision	189 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement