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FDA 510(k)

SEMINAL FLUID COLLECTION KIT II

K-Number: K954791 · 1996-01-05

ApplicantApex Medical Technologies, Inc.
Decision Date1996-01-05
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SEMINAL FLUID COLLECTION KIT II is the device name listed in this FDA 510(k) record. The listed applicant is Apex Medical Technologies, Inc.. It received FDA 510(k) clearance on 1996-01-05 under 510(k) number K954791. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEMINAL FLUID COLLECTION KIT II?

SEMINAL FLUID COLLECTION KIT II is a medical device that received FDA 510(k) clearance on 1996-01-05. The listed applicant is Apex Medical Technologies, Inc.. The 510(k) number is K954791.

When did SEMINAL FLUID COLLECTION KIT II receive FDA 510(k) clearance?

SEMINAL FLUID COLLECTION KIT II received FDA 510(k) clearance on 1996-01-05, under 510(k) number K954791.

Who is the listed applicant for SEMINAL FLUID COLLECTION KIT II?

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

What is the FDA product code for SEMINAL FLUID COLLECTION KIT II?

The FDA product code for SEMINAL FLUID COLLECTION KIT II is HIS.

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Other records listing Apex Medical Technologies, Inc. as applicant

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Related Devices (Code: HIS)

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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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