510(k) K024337
- Device
- GENERAL SEMEN ANALYSIS (GSA) KIT
- Applicant
- Bioshaf , Ltd.
- 510(k) number
- K024337
- Product code
- POV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-07-03
- Date received
- 2002-12-27
- Regulation
- 864.5220
- Classification name
- Semen Analysis Device
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- TOM TSAKERIS
- Address
- 16809 Briardale Rd. Rockville MD US 20855 20855
FDA Registration Numbers
- 1832894
- 3007800906
- 3014295858
- 3016090200
- 3011260354
- 2246703
- 3014053517
- 3043196750
- 3015550658
- 1221433
- 3005360469
- 1216677
- 3003646592
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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| K172514 | Trak Plus Male Fertility Testing System | Sandstone Diagnostics, Inc. | 2017-11-17 |
| K161493 | YO Home Sperm Test | Medical Electronic Systems , Ltd. | 2016-11-08 |
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| K100341 | SPERMCHECK FERTILITY | Princeton BioMeditech Corp. | 2010-05-04 |
| K073039 | SPERMCHECK VASECTOMY | Princeton BioMeditech Corp. | 2008-01-24 |
| K071737 | GENERAL SEMEN ANALYSIS KIT | Dyn-Bioshaf (2006) , Ltd. | 2007-10-25 |