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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name antiserum, cf, varicella-zoster
510(k) Number K883427
Device Name VIRGO(R) VZV-IGG ELISA
Applicant
ELECTRO-NUCLEONICS, INC.
8310 GUILFORD RD.
COLUMBIA,  MD  21046
Applicant Contact KAREN DARCY
Correspondent
ELECTRO-NUCLEONICS, INC.
8310 GUILFORD RD.
COLUMBIA,  MD  21046
Correspondent Contact KAREN DARCY
Regulation Number866.3900
Classification Product Code
GQX  
Date Received08/15/1988
Decision Date 03/10/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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