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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Groups, Streptococcus Spp.
510(k) Number K851132
Device Name LATEX AGGLUTINATION TEST
Applicant
New Horizons Diagnostics Co.
10220 Old Columbia Rd.
Columbia,  MD  21046
Applicant Contact LAWRENCE LOOMIS
Correspondent
New Horizons Diagnostics Co.
10220 Old Columbia Rd.
Columbia,  MD  21046
Correspondent Contact LAWRENCE LOOMIS
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received03/21/1985
Decision Date 07/05/1985
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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