Cleared Traditional

BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO

K912838 · Baxter Diagnostics, Inc. · Microbiology
Sep 1991
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K912838 is an FDA 510(k) clearance for the BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO, a Respiratory Syncytial Virus, Antigen, Antibody, Ifa (Class I — General Controls, product code LKT), submitted by Baxter Diagnostics, Inc. (Bellevue, US). The FDA issued a Cleared decision on September 27, 1991, 93 days after receiving the submission on June 26, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3480.

Submission Details

510(k) Number K912838 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 1991
Decision Date September 27, 1991
Days to Decision 93 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LKT — Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3480

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