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SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)

K941860 Class II Traditional
Decision Date
1994-09-14
Sponsor / Applicant
Helena Laboratories

Technical Specification

510(k) Submission ID K941860
Product Code GGN
Medical Specialty / Panel Hematology
Regulation Citation 21 CFR 864.5425
Decision Date 1994-09-14
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.) received FDA 510(k) clearance under submission number K941860, sponsored by Helena Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1994-09-14.

Classification & Regulation

This clearance is catalogued under FDA product code GGN and 21 CFR 864.5425, within the Hematology review panel as a Class II device.