Cleared Special

BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT

K003204 · Intracel Corp. · Microbiology
Nov 2000
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K003204 is an FDA 510(k) clearance for the BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT, a Antisera, Cf, Influenza Virus A, B, C (Class I — General Controls, product code GNW), submitted by Intracel Corp. (Rockville, US). The FDA issued a Cleared decision on November 7, 2000, 25 days after receiving the submission on October 13, 2000. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3330.

Submission Details

510(k) Number K003204 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 2000
Decision Date November 07, 2000
Days to Decision 25 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code GNW — Antisera, Cf, Influenza Virus A, B, C
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3330

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