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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY. 510(k) Number: K153683 B. Purpose for Submission: Clearance of a new device C. Measured: Sperm concentration D. Type of Test: Centrifuged

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What is sperm concentration?

Sperm concentration is the measurement of the number of sperm per milliliter of semen.

Who is required to file sperm concentration?

Individuals undergoing fertility evaluations or treatments may be required to file sperm concentration.

How to fill out sperm concentration?

Sperm concentration can be filled out by collecting a semen sample and having it analyzed by a laboratory.

What is the purpose of sperm concentration?

The purpose of sperm concentration is to assess the fertility potential of an individual.

What information must be reported on sperm concentration?

The report on sperm concentration must include the number of sperm per milliliter of semen.

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