Cleared Traditional

IMMILITE TOTAL IGE

K960067 · Diagnostic Products Corp. · Immunology
Feb 1996
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K960067 is an FDA 510(k) clearance for the IMMILITE TOTAL IGE, a Radioimmunoassay, Immunoglobulins (d, E) (Class II — Special Controls, product code JHR), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on February 14, 1996, 40 days after receiving the submission on January 5, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K960067 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 1996
Decision Date February 14, 1996
Days to Decision 40 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JHR — Radioimmunoassay, Immunoglobulins (d, E)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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