Cleared Traditional

QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS

K063864 · Medical Electronic Systems , Ltd. · Hematology

Mar 2007

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K063864 is an FDA 510(k) clearance for the QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS, a Semen Analysis Device (Class II — Special Controls, product code POV), submitted by Medical Electronic Systems , Ltd. (Los Altos, US). The FDA issued a Cleared decision on March 26, 2007, 87 days after receiving the submission on December 29, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number	K063864 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 2006
Decision Date	March 26, 2007
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement

Device Classification

Product Code	POV — Semen Analysis Device
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.5220
Definition	Device Used To Evaluate One Or More Human Semen Parameters Including Semen Volume, Sperm Concentration, Total Sperm Number, Sperm Motility, Sperm Morphology, Sperm Vitality, White Blood Cell Concentration, And Ph.