Cleared Traditional

K911473 - EBNA STAT TEST KIT
(FDA 510(k) Clearance)

K911473 · Whittaker Bioproducts, Inc. · Microbiology

Sep 1991

Decision

174d

Days

Class 1

Risk

K911473 is an FDA 510(k) clearance for the EBNA STAT TEST KIT, a Test, Antigen, Nuclear, Epstein-barr Virus (Class I — General Controls, product code LLM), submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on September 25, 1991, 174 days after receiving the submission on April 4, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number	K911473 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 04, 1991
Decision Date	September 25, 1991
Days to Decision	174 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—