Cleared Traditional

MININEPH HUMAN RHEUMATOID FACTOR KIT

K041891 · The Binding Site · Immunology
Nov 2004
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K041891 is an FDA 510(k) clearance for the MININEPH HUMAN RHEUMATOID FACTOR KIT, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by The Binding Site (Santa Monica, US). The FDA issued a Cleared decision on November 5, 2004, 116 days after receiving the submission on July 12, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number K041891 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2004
Decision Date November 05, 2004
Days to Decision 116 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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