Cleared Traditional

K884194 - PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT
(FDA 510(k) Clearance)

K884194 · Baxter Diagnostics, Inc. · Microbiology
Nov 1988
Decision
47d
Days
Class 1
Risk

K884194 is an FDA 510(k) clearance for the PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT, a Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4 (Class I — General Controls, product code GQS), submitted by Baxter Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on November 22, 1988, 47 days after receiving the submission on October 6, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3400.

Submission Details

510(k) Number K884194 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 1988
Decision Date November 22, 1988
Days to Decision 47 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GQS — Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3400

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