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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Human Chorionic Gonadotropin
510(k) Number K941983
Device Name SEALITE SCIENCES INC.
Applicant
Sealite Sciences, Inc.
187 Ben Burton Cir.
Bogart,  GA  30622
Applicant Contact DAVID F SMITH, PH.D
Correspondent
Sealite Sciences, Inc.
187 Ben Burton Cir.
Bogart,  GA  30622
Correspondent Contact DAVID F SMITH, PH.D
Regulation Number862.1155
Classification Product Code
DHA  
Date Received04/25/1994
Decision Date 08/18/1994
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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