Cleared Traditional

TEST, RHEUMATOID FACTOR

K955086 · Polymedco, Inc. · Immunology
Dec 1995
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K955086 is an FDA 510(k) clearance for the TEST, RHEUMATOID FACTOR, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on December 20, 1995, 43 days after receiving the submission on November 7, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number K955086 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 1995
Decision Date December 20, 1995
Days to Decision 43 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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