Cleared Traditional

RHEUMACOL RHEUMATOID FACTOR TEST

K972456 · Immunostics Inc., · Immunology
Nov 1997
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K972456 is an FDA 510(k) clearance for the RHEUMACOL RHEUMATOID FACTOR TEST, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on November 25, 1997, 147 days after receiving the submission on July 1, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number K972456 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1997
Decision Date November 25, 1997
Days to Decision 147 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DHR — System, Test, Rheumatoid Factor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5775

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