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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Luteinizing Hormone
510(k) Number K943188
Device Name SEALITE SCIENCE, INC. AQUALITE(R) LH
Applicant
SEALITE SCIENCES, INC.
187 BEN BURTON CIRCLE
BOGART,  GA  30622
Applicant Contact DAVID F SMITH
Correspondent
SEALITE SCIENCES, INC.
187 BEN BURTON CIRCLE
BOGART,  GA  30622
Correspondent Contact DAVID F SMITH
Regulation Number862.1485
Classification Product Code
CEP  
Date Received07/05/1994
Decision Date 10/20/1994
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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