SQA V, SPERM QUALITY ANALYZER
FDA 510(k) clearance K021746 · decided 2002-09-20
Clearance details
- K-number
- K021746
- Device name
- SQA V, SPERM QUALITY ANALYZER
- Applicant
- Medical Electronic Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2002-05-28
- Decision date
- 2002-09-20
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- POV
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Beverly Hills, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.