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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 K864731
Device Name OCEAN SCIENTIFIC VDRL TEST
Applicant
Ocean Scientific, Inc.
3740 Express Dr. S.
Islandia,  NY  11779
Applicant Contact NICHOLAS VERNOLA
Correspondent
Ocean Scientific, Inc.
3740 Express Dr. S.
Islandia,  NY  11779
Correspondent Contact NICHOLAS VERNOLA
Regulation Number866.3820
Classification Product Code
GMQ  
Date Received12/04/1986
Decision Date 03/10/1987
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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