Cleared Traditional

IMMULITE TOTAL IGE

K931703 · Diagnostic Products Corp. · Immunology
Aug 1993
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K931703 is an FDA 510(k) clearance for the IMMULITE 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 August 16, 1993, 132 days after receiving the submission on April 6, 1993. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K931703 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 1993
Decision Date August 16, 1993
Days to Decision 132 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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