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NRF — Material, Quality Control, Semen Analysis Class II

FDA Device Classification

Classification Details

Product Code
NRF
Device Class
Class II
Regulation Number
864.8625
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Definition

A semen analysis quality control material is a device used to determine the accuracy and precision of manual, semiautomated, and automated determinations of semen analysis parameters such as pH, sperm concentration, total sperm number, motility, morphology, vitality, and white blood cells.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K042750bioscreenQC-BEADSOctober 29, 2004
K041600medical electronics systemsQWIKCHECK-BEADSJuly 27, 2004
K041240fertility solutionsSEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYEDJune 2, 2004