Cleared Traditional

COLOR-SLIDE RF

K981496 · Seradyn, Inc. · Immunology
Jun 1998
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K981496 is an FDA 510(k) clearance for the COLOR-SLIDE RF, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 15, 1998, 49 days after receiving the submission on April 27, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number K981496 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 1998
Decision Date June 15, 1998
Days to Decision 49 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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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