NRF · Class II · 21 CFR 864.8625

FDA Product Code NRF: Material, Quality Control, Semen Analysis

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.

Leading manufacturers include Fertility Solutions, Inc., Medical Electronics Systems , Ltd. and Bioscreen, Inc..

3
Total
3
Cleared
30d
Avg days
2004
Since

FDA 510(k) Cleared Material, Quality Control, Semen Analysis Devices (Product Code NRF)

3 devices
1–3 of 3
Cleared Oct 29, 2004
QC-BEADS
K042750
Bioscreen, Inc.
Hematology · 25d
Cleared Jul 27, 2004
QWIKCHECK-BEADS
K041600
Medical Electronics Systems , Ltd.
Hematology · 43d
Cleared Jun 02, 2004
SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED
K041240
Fertility Solutions, Inc.
Hematology · 22d

About Product Code NRF - Regulatory Context