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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Syncytial Virus, Antigen, Antibody, Ifa
510(k) Number K983336
Device Name PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1
Applicant
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Applicant Contact EDWARD M LEVINE
Correspondent
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Correspondent Contact EDWARD M LEVINE
Regulation Number866.3480
Classification Product Code
LKT  
Subsequent Product Codes
GNX   GNY   GQS  
Date Received09/23/1998
Decision Date 03/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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