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OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT

K984145 Class II Traditional
Decision Date
1998-12-23
Sponsor / Applicant
Olympus Diagnostica GmbH

Technical Specification

510(k) Submission ID K984145
Product Code DDR
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.5680
Decision Date 1998-12-23
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT received FDA 510(k) clearance under submission number K984145, sponsored by Olympus Diagnostica GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1998-12-23.

Classification & Regulation

This clearance is catalogued under FDA product code DDR and 21 CFR 866.5680, within the Immunology review panel as a Class II device.