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REFERENCE CHECK, CATALOG NUMBER-RCN-10

K013708 Class II Traditional
Decision Date
2001-12-10
Sponsor / Applicant
Precision Biologic

Technical Specification

510(k) Submission ID K013708
Product Code GIZ
Medical Specialty / Panel Hematology
Regulation Citation 21 CFR 864.5425
Decision Date 2001-12-10
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

REFERENCE CHECK, CATALOG NUMBER-RCN-10 received FDA 510(k) clearance under submission number K013708, sponsored by Precision Biologic. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2001-12-10.

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.