Cleared Traditional

SPERMCHECK VASECTOMY

K073039 · Princeton BioMeditech Corp. · Hematology

Jan 2008

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K073039 is an FDA 510(k) clearance for the SPERMCHECK VASECTOMY, 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 January 24, 2008, 87 days after receiving the submission on October 29, 2007. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number	K073039 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 29, 2007
Decision Date	January 24, 2008
Days to Decision	87 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.