Cleared Traditional

ROTAVIRUS BIO-ENZABEAD SCREEN KIT

K834443 · Litton Bionetics · Immunology

Mar 1984

Decision

91d

Days

Class 1

Risk

About This 510(k) Submission

K834443 is an FDA 510(k) clearance for the ROTAVIRUS BIO-ENZABEAD SCREEN KIT, a Enzyme Linked Immunoabsorbent Assay, Rotavirus (Class I — General Controls, product code LIQ), submitted by Litton Bionetics (Walker, US). The FDA issued a Cleared decision on March 16, 1984, 91 days after receiving the submission on December 16, 1983. This device falls under the Immunology review panel. Regulated under 21 CFR 866.3405.

Submission Details

510(k) Number	K834443 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 1983
Decision Date	March 16, 1984
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—