Cleared Traditional

RHEUMAJET CRP

K910686 · Biokit USA, Inc. · Immunology
Mar 1991
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K910686 is an FDA 510(k) clearance for the RHEUMAJET CRP, a System, Test, C-reactive Protein (Class II — Special Controls, product code DCN), submitted by Biokit USA, Inc. (Barcelona, ES). The FDA issued a Cleared decision on March 19, 1991, 28 days after receiving the submission on February 19, 1991. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K910686 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 1991
Decision Date March 19, 1991
Days to Decision 28 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DCN — System, Test, C-reactive Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5270

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