Cleared Traditional

IMMUNO RA UNDILUTED

K926569 · Immunostics Co., Inc. · Immunology
Apr 1993
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K926569 is an FDA 510(k) clearance for the IMMUNO RA UNDILUTED, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by Immunostics Co., Inc. (Ocean, US). The FDA issued a Cleared decision on April 6, 1993, 96 days after receiving the submission on December 31, 1992. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number K926569 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 1992
Decision Date April 06, 1993
Days to Decision 96 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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