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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, parathyroid hormone
510(k) Number K970483
Device Name AQUALITE INTACT PTH
Applicant
SEALITE SCIENCES, INC.
3000 NORTHWOODS PKWY., #200
NORCROSS,  GA  30071
Applicant Contact CATHRYN N CAMBRIA
Correspondent
SEALITE SCIENCES, INC.
3000 NORTHWOODS PKWY., #200
NORCROSS,  GA  30071
Correspondent Contact CATHRYN N CAMBRIA
Regulation Number862.1545
Classification Product Code
CEW  
Date Received02/10/1997
Decision Date 04/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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