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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Cf, Toxoplasma Gondii
510(k) Number K864981
Device Name TOXOPLASMA GONDII
Applicant
Virion (U.S.), Inc.
4 Upperfield Rd.
Morristown,  NJ  07960
Applicant Contact EDWIN H LENNETTE,MD
Correspondent
Virion (U.S.), Inc.
4 Upperfield Rd.
Morristown,  NJ  07960
Correspondent Contact EDWIN H LENNETTE,MD
Regulation Number866.3780
Classification Product Code
GMN  
Date Received12/22/1986
Decision Date 10/30/1987
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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