GENERAL SEMEN ANALYSIS (GSA) KIT
FDA 510(k) clearance K024337 · decided 2003-07-03
Clearance details
- K-number
- K024337
- Device name
- GENERAL SEMEN ANALYSIS (GSA) KIT
- Applicant
- Bioshaf , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-12-27
- Decision date
- 2003-07-03
- Days to decision
- 188 days
- Clearance type
- Traditional
- Product code
- POV
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.