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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), Parainfluenza Virus 1-4
510(k) Number K905385
Device Name P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN
Applicant
Virion (U.S.), Inc.
4 Upperfield Rd.
Morristown,  NJ  07960
Applicant Contact HAUSLER, JR.
Correspondent
Virion (U.S.), Inc.
4 Upperfield Rd.
Morristown,  NJ  07960
Correspondent Contact HAUSLER, JR.
Regulation Number866.3400
Classification Product Code
GQS  
Date Received11/30/1990
Decision Date 03/21/1991
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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