Cleared Traditional

RUBELLA BIO-BEAD SCREEN KIT

K791610 · Litton Bionetics · Microbiology
Nov 1979
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K791610 is an FDA 510(k) clearance for the RUBELLA BIO-BEAD SCREEN KIT, a Antigen, Ha (including Ha Control), Rubella (Class II — Special Controls, product code GOL), submitted by Litton Bionetics (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979, 84 days after receiving the submission on August 21, 1979. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K791610 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1979
Decision Date November 13, 1979
Days to Decision 84 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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