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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Nontreponemal, All
510(k) Number K993633
Device Name SYNTHETIC VDRL ANTIGEN
Applicant
Centers for Disease Control and Prevention
1600 Clifton Rd., NE
Atlanta,  GA  30333
Applicant Contact VICTORIA POPE
Correspondent
Centers for Disease Control and Prevention
1600 Clifton Rd., NE
Atlanta,  GA  30333
Correspondent Contact VICTORIA POPE
Regulation Number866.3820
Classification Product Code
GMQ  
Date Received10/27/1999
Decision Date 02/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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