Cleared Traditional

TURBO-RAST SPECIFIC IGE ASSAY

K903000 · Ventrex Laboratories, Inc. · Immunology
Jul 1990
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K903000 is an FDA 510(k) clearance for the TURBO-RAST SPECIFIC IGE ASSAY, a Radioimmunoassay, Immunoglobulins (d, E) (Class II — Special Controls, product code JHR), submitted by Ventrex Laboratories, Inc. (Portland, US). The FDA issued a Cleared decision on July 31, 1990, 22 days after receiving the submission on July 9, 1990. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K903000 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 1990
Decision Date July 31, 1990
Days to Decision 22 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

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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