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FDA 510(k)

SPERMCHECK FERTILITY

K-Number: K100341 · 2010-05-04

ApplicantPrinceton BioMeditech Corp.
Decision Date2010-05-04
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SPERMCHECK FERTILITY is the device name listed in this FDA 510(k) record. The listed applicant is Princeton BioMeditech Corp.. It received FDA 510(k) clearance on 2010-05-04 under 510(k) number K100341. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPERMCHECK FERTILITY?

SPERMCHECK FERTILITY is a medical device that received FDA 510(k) clearance on 2010-05-04. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K100341.

When did SPERMCHECK FERTILITY receive FDA 510(k) clearance?

SPERMCHECK FERTILITY received FDA 510(k) clearance on 2010-05-04, under 510(k) number K100341.

Who is the listed applicant for SPERMCHECK FERTILITY?

The FDA 510(k) record lists Princeton BioMeditech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPERMCHECK FERTILITY?

The FDA product code for SPERMCHECK FERTILITY is POV.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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