Cleared Traditional

K800789 - RUBELLA BIO-BEAD TITRATION KIT
(FDA 510(k) Clearance)

K800789 · Litton Bionetics · Microbiology

Jun 1980

Decision

83d

Days

Class 2

Risk

K800789 is an FDA 510(k) clearance for the RUBELLA BIO-BEAD TITRATION KIT. This device is classified as 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 June 30, 1980, 83 days after receiving the submission on April 8, 1980.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number	K800789 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 08, 1980
Decision Date	June 30, 1980
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—