Cleared Traditional

ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM

K972406 · Immunoprobe, Inc. · Microbiology
Dec 1997
Decision
179d
Days
Class 1
Risk

About This 510(k) Submission

K972406 is an FDA 510(k) clearance for the ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM, a Antigens, Cf (including Cf Control), Adenovirus 1-33 (Class I — General Controls, product code GOD), submitted by Immunoprobe, Inc. (Frederick, US). The FDA issued a Cleared decision on December 22, 1997, 179 days after receiving the submission on June 26, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3020.

Submission Details

510(k) Number K972406 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 1997
Decision Date December 22, 1997
Days to Decision 179 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GOD — Antigens, Cf (including Cf Control), Adenovirus 1-33
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3020

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