Cleared Traditional

EIA RUBELLA-G

K802339 · Beckman Instruments, Inc. · Microbiology
Dec 1980
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K802339 is an FDA 510(k) clearance for the EIA RUBELLA-G, a Antigen, Ha (including Ha Control), Rubella (Class II — Special Controls, product code GOL), submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 18, 1980, 83 days after receiving the submission on September 26, 1980. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K802339 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 1980
Decision Date December 18, 1980
Days to Decision 83 days
Submission Type Traditional
Review Panel Microbiology (MI)
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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