Cleared Traditional

TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER

K891683 · Helena Laboratories · Immunology
Apr 1989
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K891683 is an FDA 510(k) clearance for the TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER, a Iga, Fitc, Antigen, Antiserum, Control (Class II — Special Controls, product code CZN), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on April 12, 1989, 21 days after receiving the submission on March 22, 1989. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K891683 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 1989
Decision Date April 12, 1989
Days to Decision 21 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code CZN — Iga, Fitc, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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