FDA 510(k), K021746, SQA V, SPERM QUALITY ANALYZER
FDA 510(k), K021746, SQA V, SPERM QUALITY ANALYZER
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510(K) Number: K021746
Device Name: SQA V, SPERM QUALITY ANALYZER
Manufacturer: MEDICAL ELECTRONIC SYSTEMS, LLC
Device Classification Name: semen analysis device
Regulation Number: 864.5220
Classification Product Code: POV
Date Received: 05/28/2002
Decision Date: 09/20/2002
Regulation Medical Specialty: Hematology
Device Name: SQA V, SPERM QUALITY ANALYZER
Manufacturer: MEDICAL ELECTRONIC SYSTEMS, LLC
Device Classification Name: semen analysis device
Regulation Number: 864.5220
Classification Product Code: POV
Date Received: 05/28/2002
Decision Date: 09/20/2002
Regulation Medical Specialty: Hematology