Cleared Traditional

POLYSLIT IFE KIT

K990998 · Helena Laboratories · Immunology
Jun 1999
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K990998 is an FDA 510(k) clearance for the POLYSLIT IFE KIT, a Immunoelectrophoretic, Immunoglobulins, (g, A, M) (Class II — Special Controls, product code CFF), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on June 28, 1999, 95 days after receiving the submission on March 25, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K990998 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 1999
Decision Date June 28, 1999
Days to Decision 95 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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