Cleared Traditional

DIARLEX ROTA-ADENO

K942286 · Orion Diagnostica, Inc. · Microbiology
Dec 1994
Decision
236d
Days
Class 1
Risk

About This 510(k) Submission

K942286 is an FDA 510(k) clearance for the DIARLEX ROTA-ADENO, a Enzyme Linked Immunoabsorbent Assay, Rotavirus (Class I — General Controls, product code LIQ), submitted by Orion Diagnostica, Inc. (02101 Espoo, FI). The FDA issued a Cleared decision on December 14, 1994, 236 days after receiving the submission on April 22, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3405.

Submission Details

510(k) Number K942286 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 1994
Decision Date December 14, 1994
Days to Decision 236 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

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