510(k) K071737
- Device
- GENERAL SEMEN ANALYSIS KIT
- Applicant
- Dyn-Bioshaf (2006) , Ltd.
- 510(k) number
- K071737
- Product code
- POV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-10-25
- Date received
- 2007-06-26
- Regulation
- 864.5220
- Classification name
- Semen Analysis Device
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- THOMAS M 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
510(k) summary PDF not indicated by FDA
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