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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K863976
Device Name OCEAN SCIENTIFIC VACUTEST
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 Number862.1675
Classification Product Code
JKA  
Date Received10/14/1986
Decision Date 10/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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