Cleared Traditional

ROCHE CRP T CONTROL N

K982087 · Roche Diagnostic Systems, Inc. · Immunology
Aug 1998
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K982087 is an FDA 510(k) clearance for the ROCHE CRP T CONTROL N, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on August 18, 1998, 64 days after receiving the submission on June 15, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K982087 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 1998
Decision Date August 18, 1998
Days to Decision 64 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DCK — C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5270

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