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SEMINAL FLUID COLLECTION KIT(TM)

K864473 Class II Traditional
Decision Date
1986-12-03
Sponsor / Applicant
Apex Technologies, Inc.

Technical Specification

510(k) Submission ID K864473
Product Code HIS
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 884.5300
Decision Date 1986-12-03
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

SEMINAL FLUID COLLECTION KIT(TM) received FDA 510(k) clearance under submission number K864473, sponsored by Apex Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1986-12-03.

Classification & Regulation

This clearance is catalogued under FDA product code HIS and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.