Cleared Traditional

RSV OIA

K021172 · Thermo Biostar, Inc. · Microbiology
Sep 2002
Decision
154d
Days
Class 1
Risk

About This 510(k) Submission

K021172 is an FDA 510(k) clearance for the RSV OIA, a Antisera, Cf, Poliovirus 1-3 (Class I — General Controls, product code GOG), submitted by Thermo Biostar, Inc. (Boulder, US). The FDA issued a Cleared decision on September 13, 2002, 154 days after receiving the submission on April 12, 2002. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3405.

Submission Details

510(k) Number K021172 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 2002
Decision Date September 13, 2002
Days to Decision 154 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GOG — Antisera, Cf, Poliovirus 1-3
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3405