Cleared Traditional

RUBAQUICK DIAGNOSTIC KIT

K834032 · Abbott Laboratories · Hematology
Apr 1984
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K834032 is an FDA 510(k) clearance for the RUBAQUICK DIAGNOSTIC KIT, a Antigen, Ha (including Ha Control), Rubella (Class II — Special Controls, product code GOL), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 17, 1984, 147 days after receiving the submission on November 22, 1983. This device falls under the Hematology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K834032 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 1983
Decision Date April 17, 1984
Days to Decision 147 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GOL — Antigen, Ha (including Ha Control), Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510

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