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ABNORMAL REFERENCE PLASMA-IX

K895504 Class II Traditional
Decision Date
1989-10-06
Sponsor / Applicant
Medical Diagnostic Technologies, Inc.

Technical Specification

510(k) Submission ID K895504
Product Code GJT
Medical Specialty / Panel Hematology
Regulation Citation 21 CFR 864.7290
Decision Date 1989-10-06
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

ABNORMAL REFERENCE PLASMA-IX received FDA 510(k) clearance under submission number K895504, 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 1989-10-06.

Classification & Regulation

This clearance is catalogued under FDA product code GJT and 21 CFR 864.7290, within the Hematology review panel as a Class II device.