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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 (Including Cf Control), Coxsackievirus A 1-24, B 1-6
510(k) Number K921618
Device Name COXSACKIE VIRUS B1-B6 CF ANTIGENS
Applicant
Virion (U.S.), Inc.
4 Upperfield Rd.
Morristown,  NJ  07960
Applicant Contact WILLIAM J HAUSLER
Correspondent
Virion (U.S.), Inc.
4 Upperfield Rd.
Morristown,  NJ  07960
Correspondent Contact WILLIAM J HAUSLER
Regulation Number866.3145
Classification Product Code
GNG  
Date Received04/06/1992
Decision Date 06/29/1992
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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