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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Neutralization, Parainfluenza Virus 1-4
510(k) Number K933575
Device Name VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANT
Applicant
Symex Corp.
P.O. Box 690355
Tulsa,  OK  74169
Applicant Contact CRAIG D SHIMASAKI
Correspondent
Symex Corp.
P.O. Box 690355
Tulsa,  OK  74169
Correspondent Contact CRAIG D SHIMASAKI
Regulation Number866.3400
Classification Product Code
GQP  
Date Received07/23/1993
Decision Date 11/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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