510(k) K041240

Device: SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED
Applicant: FERTILITY SOLUTIONS, INC.
510(k) number: K041240
Product code: NRF
Decision: Substantially Equivalent (SESE)
Decision date: 2004-06-02
Date received: 2004-05-11
Regulation: 864.8625
Classification name: Material, Quality Control, Semen Analysis
Medical specialty: Hematology
Review panel: Hematology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: SUSAN A ROTHMANN, PH.D., HCLD
Address: 13000 Shaker Blvd. Cleveland OH US 44120 44120

FDA Registration Numbers#

3008987086
3038206980
2025606
3003750510
3014053517
3035387168
1950302
1221433
3003646592
3043127699
3016090200

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NRF #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K042750	QC-BEADS	Bioscreen, Inc.	2004-10-29
K041600	QWIKCHECK-BEADS	Medical Electronics Systems , Ltd.	2004-07-27

Legacy Summary#

summary

FDA Review#

Decision Summary