meddevicedb.com FDA Device Reference

MICROSCOPE COVER GLASSES

K872874 Class I Traditional
Decision Date
1987-08-10
Sponsor / Applicant
Abco Dealers, Inc.

Technical Specification

510(k) Submission ID K872874
Product Code KES
Medical Specialty / Panel Pathology
Regulation Citation 21 CFR 864.3010
Decision Date 1987-08-10
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

MICROSCOPE COVER GLASSES received FDA 510(k) clearance under submission number K872874, sponsored by Abco Dealers, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1987-08-10.

Classification & Regulation

This clearance is catalogued under FDA product code KES and 21 CFR 864.3010, within the Pathology review panel as a Class I device.