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REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM

K874809 Class I Traditional
Decision Date
1988-01-07
Sponsor / Applicant
Biotrol, USA, Inc.

Technical Specification

510(k) Submission ID K874809
Product Code JJY
Medical Specialty / Panel Clinical Chemistry
Regulation Citation 21 CFR 862.1660
Decision Date 1988-01-07
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM received FDA 510(k) clearance under submission number K874809, sponsored by Biotrol, USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1988-01-07.

Classification & Regulation

This clearance is catalogued under FDA product code JJY and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.