Cleared Traditional

SLIDEX ROTA-KIT 2

K895805 · Vitek Systems, Inc. · Microbiology
Feb 1991
Decision
516d
Days
Class 1
Risk

About This 510(k) Submission

K895805 is an FDA 510(k) clearance for the SLIDEX ROTA-KIT 2, a Enzyme Linked Immunoabsorbent Assay, Rotavirus (Class I — General Controls, product code LIQ), submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on February 26, 1991, 516 days after receiving the submission on September 28, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3405.

Submission Details

510(k) Number K895805 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 1989
Decision Date February 26, 1991
Days to Decision 516 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LIQ — Enzyme Linked Immunoabsorbent Assay, Rotavirus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3405