meddevicedb.com FDA Device Reference

BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B

K012811 Class II Traditional
Decision Date
2002-02-11
Sponsor / Applicant
Humagen Fertility Diagnostics, Inc.

Technical Specification

510(k) Submission ID K012811
Product Code MQH
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 884.6130
Decision Date 2002-02-11
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B received FDA 510(k) clearance under submission number K012811, sponsored by Humagen Fertility Diagnostics, 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 2002-02-11.

Classification & Regulation

This clearance is catalogued under FDA product code MQH and 21 CFR 884.6130, within the Obstetrics/Gynecology review panel as a Class II device.