Cleared Traditional

IMMUNO-RA

K834391 · Immunostics Co., Inc. · Microbiology
Feb 1984
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K834391 is an FDA 510(k) clearance for the IMMUNO-RA, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by Immunostics Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on February 3, 1984, 51 days after receiving the submission on December 14, 1983. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number K834391 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1983
Decision Date February 03, 1984
Days to Decision 51 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

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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