Cleared Traditional

PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)

K943317 · Diagnostic Products Corp. · Microbiology
Dec 1994
Decision
161d
Days
Class 1
Risk

About This 510(k) Submission

K943317 is an FDA 510(k) clearance for the PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV), a Respiratory Syncytial Virus, Antigen, Antibody, Ifa (Class I — General Controls, product code LKT), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on December 19, 1994, 161 days after receiving the submission on July 11, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3480.

Submission Details

510(k) Number K943317 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 1994
Decision Date December 19, 1994
Days to Decision 161 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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