meddevicedb.com FDA Device Reference

COAGULATION REFERENCE PLASMA, NORMAL

K905203 Class II Traditional
Decision Date
1990-12-28
Sponsor / Applicant
Medical Diagnostic Technologies, Inc.

Technical Specification

510(k) Submission ID K905203
Product Code GIZ
Medical Specialty / Panel Hematology
Regulation Citation 21 CFR 864.5425
Decision Date 1990-12-28
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

COAGULATION REFERENCE PLASMA, NORMAL received FDA 510(k) clearance under submission number K905203, sponsored by Medical Diagnostic Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1990-12-28.

Classification & Regulation

This clearance is catalogued under FDA product code GIZ and 21 CFR 864.5425, within the Hematology review panel as a Class II device.