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FDA 510(k)

FERTILMARQ TEST KIT

K-Number: K983473 · 1998-12-17

ApplicantEmbryotech Laboratories, Inc.
Decision Date1998-12-17
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FERTILMARQ TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Embryotech Laboratories, Inc.. It received FDA 510(k) clearance on 1998-12-17 under 510(k) number K983473. 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 FERTILMARQ TEST KIT?

FERTILMARQ TEST KIT is a medical device that received FDA 510(k) clearance on 1998-12-17. The listed applicant is Embryotech Laboratories, Inc.. The 510(k) number is K983473.

When did FERTILMARQ TEST KIT receive FDA 510(k) clearance?

FERTILMARQ TEST KIT received FDA 510(k) clearance on 1998-12-17, under 510(k) number K983473.

Who is the listed applicant for FERTILMARQ TEST KIT?

The FDA 510(k) record lists Embryotech Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FERTILMARQ TEST KIT?

The FDA product code for FERTILMARQ TEST KIT is POV.

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Other records listing Embryotech Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K011679FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY

Related Devices (Code: 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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