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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Rubella
510(k) Number K873088
Device Name VIRGO(TM) RUBELLA IGG ELISA
Applicant
Electro-Nucleonics Laboratories, Inc.
7101 Riverwood Dr.
Columbia,  MD  21046
Applicant Contact LABREC, PHD
Correspondent
Electro-Nucleonics Laboratories, Inc.
7101 Riverwood Dr.
Columbia,  MD  21046
Correspondent Contact LABREC, PHD
Regulation Number866.3510
Classification Product Code
LFX  
Date Received08/05/1987
Decision Date 09/09/1987
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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