Cleared Traditional

PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1

K983336 · Diagnostic Products Corp. · Microbiology
Mar 1999
Decision
176d
Days
Class 1
Risk

About This 510(k) Submission

K983336 is an FDA 510(k) clearance for the PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1, 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 March 18, 1999, 176 days after receiving the submission on September 23, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3480.

Submission Details

510(k) Number K983336 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 1998
Decision Date March 18, 1999
Days to Decision 176 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

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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