Cleared Traditional

SPERMCHECK FERTILITY

K100341 · Princeton BioMeditech Corp. · Hematology

May 2010

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K100341 is an FDA 510(k) clearance for the SPERMCHECK FERTILITY, a Semen Analysis Device (Class II — Special Controls, product code POV), submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on May 4, 2010, 88 days after receiving the submission on February 5, 2010. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number	K100341 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 05, 2010
Decision Date	May 04, 2010
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF

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.