Cleared Traditional

INTERLAB IMMUNOFIXATION TEST(S)

K033187 · Interlab S.R.L. · Immunology
Nov 2003
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K033187 is an FDA 510(k) clearance for the INTERLAB IMMUNOFIXATION TEST(S), a Immunoelectrophoretic, Immunoglobulins, (g, A, M) (Class II — Special Controls, product code CFF), submitted by Interlab S.R.L. (East Stroudsburg, US). The FDA issued a Cleared decision on November 19, 2003, 49 days after receiving the submission on October 1, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K033187 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2003
Decision Date November 19, 2003
Days to Decision 49 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code CFF — Immunoelectrophoretic, Immunoglobulins, (g, A, M)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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