FDA 510(k), K012352, SQA, SPERM QUALITY ANALYZER
FDA 510(k), K012352, SQA, SPERM QUALITY ANALYZER
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510(K) Number: K012352
Device Name: SQA, SPERM QUALITY ANALYZER
Manufacturer: MEDICAL ELECTRONIC SYSTEMS, LLC
Device Classification Name: semen analysis device
Regulation Number: 864.5220
Classification Product Code: POV
Date Received: 07/25/2001
Decision Date: 09/21/2001
Regulation Medical Specialty: Hematology
Device Name: SQA, SPERM QUALITY ANALYZER
Manufacturer: MEDICAL ELECTRONIC SYSTEMS, LLC
Device Classification Name: semen analysis device
Regulation Number: 864.5220
Classification Product Code: POV
Date Received: 07/25/2001
Decision Date: 09/21/2001
Regulation Medical Specialty: Hematology