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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 K871226
Device Name SYPHILIS SEROLOGICAL REAGENTS
Applicant
New Horizons Diagnostics Co.
9110 Red Branch Rd.
Suite B
Columbia,  MD  21045
Applicant Contact CYNTHIA C ROHDE
Correspondent
New Horizons Diagnostics Co.
9110 Red Branch Rd.
Suite B
Columbia,  MD  21045
Correspondent Contact CYNTHIA C ROHDE
Regulation Number866.3820
Classification Product Code
GMQ  
Date Received03/27/1987
Decision Date 05/28/1987
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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