Cleared Traditional

MODIFIED CRP LATEX TEST

K880016 · Sclavo, Inc. · Immunology
Feb 1988
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K880016 is an FDA 510(k) clearance for the MODIFIED CRP LATEX TEST, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on February 25, 1988, 51 days after receiving the submission on January 5, 1988. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K880016 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 1988
Decision Date February 25, 1988
Days to Decision 51 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

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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