Cleared Traditional

TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410

K872834 · Helena Laboratories · Immunology
Aug 1987
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K872834 is an FDA 510(k) clearance for the TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410, a Igd, Antigen, Antiserum, Control (Class II — Special Controls, product code CZJ), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on August 12, 1987, 26 days after receiving the submission on July 17, 1987. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K872834 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 1987
Decision Date August 12, 1987
Days to Decision 26 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code CZJ — Igd, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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