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REFERENCE BUFFER PH 7.382

K831023 Class II Traditional
Decision Date
1983-06-15
Sponsor / Applicant
Fisher Scientific Co., LLC

Technical Specification

510(k) Submission ID K831023
Product Code CHL
Medical Specialty / Panel Clinical Chemistry
Regulation Citation 21 CFR 862.1120
Decision Date 1983-06-15
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

REFERENCE BUFFER PH 7.382 received FDA 510(k) clearance under submission number K831023, sponsored by Fisher Scientific Co., LLC. 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 1983-06-15.

Classification & Regulation

This clearance is catalogued under FDA product code CHL and 21 CFR 862.1120, within the Clinical Chemistry review panel as a Class II device.